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WO2019186361A1 - Conduit avec connecteur magnétique - Google Patents

Conduit avec connecteur magnétique Download PDF

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Publication number
WO2019186361A1
WO2019186361A1 PCT/IB2019/052395 IB2019052395W WO2019186361A1 WO 2019186361 A1 WO2019186361 A1 WO 2019186361A1 IB 2019052395 W IB2019052395 W IB 2019052395W WO 2019186361 A1 WO2019186361 A1 WO 2019186361A1
Authority
WO
WIPO (PCT)
Prior art keywords
plenum chamber
patient
conduit
assembly
connector assembly
Prior art date
Application number
PCT/IB2019/052395
Other languages
English (en)
Inventor
Yi Mei FOONG
Original Assignee
ResMed Pty Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by ResMed Pty Ltd filed Critical ResMed Pty Ltd
Priority to EP19777027.4A priority Critical patent/EP3773846B1/fr
Priority to US16/635,267 priority patent/US10953180B2/en
Priority to EP23210412.5A priority patent/EP4364772A3/fr
Publication of WO2019186361A1 publication Critical patent/WO2019186361A1/fr
Priority to US17/177,611 priority patent/US20210170129A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0605—Means for improving the adaptation of the mask to the patient
    • A61M16/0616—Means for improving the adaptation of the mask to the patient with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure
    • A61M16/0622—Means for improving the adaptation of the mask to the patient with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure having an underlying cushion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0666—Nasal cannulas or tubing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
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    • A61M16/0683—Holding devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816—Joints or connectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0875—Connecting tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
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    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
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    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/105—Filters
    • A61M16/106—Filters in a path
    • A61M16/107—Filters in a path in the inspiratory path
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    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/1075—Preparation of respiratory gases or vapours by influencing the temperature
    • A61M16/109—Preparation of respiratory gases or vapours by influencing the temperature the humidifying liquid or the beneficial agent
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    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
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    • A61M16/1095—Preparation of respiratory gases or vapours by influencing the temperature in the connecting tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/14—Preparation of respiratory gases or vapours by mixing different fluids, one of them being in a liquid phase
    • A61M16/16—Devices to humidify the respiration air
    • A—HUMAN NECESSITIES
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    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A61M16/208—Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
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Definitions

  • the present technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention and amelioration of respiratory-related disorders.
  • the present technology also relates to medical devices or apparatus, and their use.
  • the respiratory system of the body facilitates gas exchange.
  • the nose and mouth form the entrance to the airways of a patient.
  • the airways include a series of branching tubes, which become narrower, shorter and more numerous as they penetrate deeper into the lung.
  • the prime function of the lung is gas exchange, allowing oxygen to move from the inhaled air into the venous blood and carbon dioxide to move in the opposite direction.
  • the trachea divides into right and left main bronchi, which further divide eventually into terminal bronchioles.
  • the bronchi make up the conducting airways, and do not take part in gas exchange. Further divisions of the airways lead to the respiratory bronchioles, and eventually to the alveoli.
  • the alveolated region of the lung is where the gas exchange takes place, and is referred to as the respiratory zone. See“ Respiratory Physiology” , by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.
  • a range of respiratory disorders exist. Certain disorders may be characterised by particular events, e.g. apneas, hypopneas, and hyperpneas.
  • Examples of respiratory disorders include Obstructive Sleep Apnea (OSA), Cheyne-Stokes Respiration (CSR), respiratory insufficiency, Obesity
  • HOS Hyperventilation Syndrome
  • COPD Chronic Obstructive Pulmonary Disease
  • NMD Neuromuscular Disease
  • Obstructive Sleep Apnea a form of Sleep Disordered Breathing (SDB) is characterised by events including occlusion or obstruction of the upper air passage during sleep. It results from a combination of an abnormally small upper airway and the normal loss of muscle tone in the region of the tongue, soft palate and posterior oropharyngeal wall during sleep. The condition causes the affected patient to stop breathing for periods typically of 30 to 120 seconds in duration, sometimes 200 to 300 times per night. It often causes excessive daytime somnolence, and it may cause cardiovascular disease and brain damage. The syndrome is a common disorder, particularly in middle aged overweight males, although a person affected may have no awareness of the problem. See US Patent No. 4,944,310 (Sullivan).
  • CSR Cheyne-Stokes Respiration
  • CSR cycles are rhythmic alternating periods of waxing and waning ventilation known as CSR cycles.
  • CSR is characterised by repetitive de-oxygenation and re-oxygenation of the arterial blood. It is possible that CSR is harmful because of the repetitive hypoxia.
  • CSR is associated with repetitive arousal from sleep, which causes severe sleep disruption, increased sympathetic activity, and increased afterload. See US Patent No. 6,532,959 (Berthon-Jones).
  • Respiratory failure is an umbrella term for respiratory disorders in which the lungs are unable to inspire sufficient oxygen or exhale sufficient CO2 to meet the patient’s needs. Respiratory failure may encompass some or all of the following disorders.
  • a patient with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath on exercise.
  • Obesity Hyperventilation Syndrome is defined as the combination of severe obesity and awake chronic hypercapnia, in the absence of other known causes for hypoventilation. Symptoms include dyspnea, morning headache and excessive daytime sleepiness.
  • COPD Chronic Obstructive Pulmonary Disease
  • COPD encompasses any of a group of lower airway diseases that have certain characteristics in common. These include increased resistance to air movement, extended expiratory phase of respiration, and loss of the normal elasticity of the lung. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic tobacco smoking (primary risk factor), occupational exposures, air pollution and genetic factors.
  • Symptoms include: dyspnea on exertion, chronic cough and sputum production.
  • Neuromuscular Disease is a broad term that encompasses many diseases and ailments that impair the functioning of the muscles either directly via intrinsic muscle pathology, or indirectly via nerve pathology.
  • Some NMD patients are characterised by progressive muscular impairment leading to loss of ambulation, being wheelchair-bound, swallowing difficulties, respiratory muscle weakness and, eventually, death from respiratory failure.
  • Neuromuscular disorders can be divided into rapidly progressive and slowly progressive: (i) Rapidly progressive disorders: Characterised by muscle impairment that worsens over months and results in death within a few years (e.g. Amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) Variable or slowly progressive disorders:
  • ALS Amyotrophic lateral sclerosis
  • DMD Duchenne muscular dystrophy
  • Symptoms of respiratory failure in NMD include: increasing generalised weakness, dysphagia, dyspnea on exertion and at rest, fatigue, sleepiness, morning headache, and difficulties with concentration and mood changes.
  • Chest wall disorders are a group of thoracic deformities that result in inefficient coupling between the respiratory muscles and the thoracic cage.
  • the disorders are usually characterised by a restrictive defect and share the potential of long term hypercapnic respiratory failure.
  • Scoliosis and/or kyphoscoliosis may cause severe respiratory failure.
  • Symptoms of respiratory failure include: dyspnea on exertion, peripheral oedema, orthopnea, repeated chest infections, morning headaches, fatigue, poor sleep quality and loss of appetite.
  • a range of therapies have been used to treat or ameliorate such conditions. Furthermore, otherwise healthy individuals may take advantage of such therapies to prevent respiratory disorders from arising. However, these have a number of shortcomings.
  • CPAP Continuous Positive Airway Pressure
  • NMV Non-invasive ventilation
  • IV Invasive ventilation
  • Continuous Positive Airway Pressure (CPAP) therapy has been used to treat Obstructive Sleep Apnea (OSA).
  • OSA Obstructive Sleep Apnea
  • the mechanism of action is that continuous positive airway pressure acts as a pneumatic splint and may prevent upper airway occlusion, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall.
  • Treatment of OSA by CPAP therapy may be voluntary, and hence patients may elect not to comply with therapy if they find devices used to provide such therapy one or more of: uncomfortable, difficult to use, expensive and aesthetically unappealing.
  • Non-invasive ventilation provides ventilatory support to a patient through the upper airways to assist the patient breathing and/or maintain adequate oxygen levels in the body by doing some or all of the work of breathing.
  • the ventilatory support is provided via a non-invasive patient interface.
  • NIV has been used to treat CSR and respiratory failure, in forms such as OHS, COPD, NMD and Chest Wall disorders. In some forms, the comfort and effectiveness of these therapies may be improved.
  • Invasive ventilation provides ventilatory support to patients that are no longer able to effectively breathe themselves and may be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these therapies may be improved.
  • These therapies may be provided by a treatment system or device. Such systems and devices may also be used to screen, diagnose, or monitor a condition without treating it.
  • a treatment system may comprise a Respiratory Pressure Therapy Device (RPT device), an air circuit, a humidifier, a patient interface, and data management.
  • RPT device Respiratory Pressure Therapy Device
  • Another form of treatment system is a mandibular repositioning device.
  • a patient interface may be used to interface respiratory equipment to its wearer, for example by providing a flow of air to an entrance to the airways.
  • the flow of air may be provided via a mask to the nose and/or mouth, a tube to the mouth or a tracheostomy tube to the trachea of a patient.
  • the patient interface may form a seal, e.g., with a region of the patient's face, to facilitate the delivery of gas at a pressure at sufficient variance with ambient pressure to effect therapy, e.g., at a positive pressure of about 10 cmFhO relative to ambient pressure.
  • the patient interface may not include a seal sufficient to facilitate delivery to the airways of a supply of gas at a positive pressure of about 10 cmFhO.
  • Certain other mask systems may be functionally unsuitable for the present field.
  • purely ornamental masks may be unable to maintain a suitable pressure.
  • Mask systems used for underwater swimming or diving may be configured to guard against ingress of water from an external higher pressure, but not to maintain air internally at a higher pressure than ambient.
  • Certain masks may be clinically unfavourable for the present technology e.g. if they block airflow via the nose and only allow it via the mouth.
  • Certain masks may be uncomfortable or impractical for the present technology if they require a patient to insert a portion of a mask structure in their mouth to create and maintain a seal via their lips.
  • Certain masks may be impractical for use while sleeping, e.g. for sleeping while lying on one’s side in bed with a head on a pillow.
  • the design of a patient interface presents a number of challenges.
  • the face has a complex three-dimensional shape.
  • the size and shape of noses and heads varies considerably between individuals. Since the head includes bone, cartilage and soft tissue, different regions of the face respond differently to mechanical forces.
  • the jaw or mandible may move relative to other bones of the skull. The whole head may move during the course of a period of respiratory therapy.
  • masks suffer from being one or more of obtrusive, aesthetically undesirable, costly, poorly fitting, difficult to use, and uncomfortable especially when worn for long periods of time or when a patient is unfamiliar with a system. Wrongly sized masks can give rise to reduced compliance, reduced comfort and poorer patient outcomes.
  • Masks designed solely for aviators, masks designed as part of personal protection equipment (e.g. filter masks), SCUBA masks, or for the administration of anaesthetics may be tolerable for their original application, but nevertheless such masks may be undesirably uncomfortable to be worn for extended periods of time, e.g., several hours. This discomfort may lead to a reduction in patient compliance with therapy. This is even more so if the mask is to be worn during sleep.
  • CPAP therapy is highly effective to treat certain respiratory disorders, provided patients comply with therapy. If a mask is uncomfortable, or difficult to use a patient may not comply with therapy. Since it is often recommended that a patient regularly wash their mask, if a mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may not clean their mask and this may impact on patient compliance.
  • a mask for other applications e.g. aviators
  • a mask designed for use in beating sleep disordered breathing may be suitable for other applications.
  • patient interfaces for delivery of CPAP during sleep form a distinct field.
  • Patient interfaces may include a seal-forming structure. Since it is in direct contact with the patient’s face, the shape and configuration of the seal-forming structure can have a direct impact the effectiveness and comfort of the patient interface.
  • a patient interface may be partly characterised according to the design intent of where the seal- forming structure is to engage with the face in use.
  • a seal-forming structure may comprise a first sub-portion to form a seal around the left naris and a second sub-portion to form a seal around the right naris.
  • a seal-forming structure may comprise a single element that surrounds both nares in use. Such single element may be designed to for example overlay an upper lip region and a nasal bridge region of a face.
  • a seal-forming structure may comprise an element that surrounds a mouth region in use, e.g. by forming a seal on a lower lip region of a face.
  • a seal-forming structure may comprise a single element that surrounds both nares and a mouth region in use.
  • These different types of patient interfaces may be known by a variety of names by their manufacturer including nasal masks, full-face masks, nasal pillows, nasal puffs and oro-nasal masks.
  • a seal-forming structure that may be effective in one region of a patient’s face may be inappropriate in another region, e.g. because of the different shape, structure, variability and sensitivity regions of the patient’s face. For example, a seal on swimming goggles that overlays a patient’s forehead may not be appropriate to use on a patient’s nose.
  • Certain seal-forming structures may be designed for mass manufacture such that one design fit and be comfortable and effective for a wide range of different face shapes and sizes. To the extent to which there is a mismatch between the shape of the patient’s face, and the seal-forming structure of the mass-manufactured patient interface, one or both must adapt in order for a seal to form.
  • seal-forming structure extends around the periphery of the patient interface, and is intended to seal against the patient's face when force is applied to the patient interface with the seal-forming structure in confronting engagement with the patient's face.
  • the seal-forming structure may include an air or fluid filled cushion, or a moulded or formed surface of a resilient seal element made of an elastomer such as a rubber.
  • Another type of seal-forming structure incorporates a flap seal of thin material positioned about the periphery of the mask so as to provide a self-sealing action against the face of the patient when positive pressure is applied within the mask.
  • a flap seal of thin material positioned about the periphery of the mask so as to provide a self-sealing action against the face of the patient when positive pressure is applied within the mask.
  • additional force may be required to achieve a seal, or the mask may leak.
  • the shape of the seal-forming structure does not match that of the patient, it may crease or buckle in use, giving rise to leaks.
  • seal-forming structure may comprise a friction-fit element, e.g. for insertion into a naris, however some patients find these
  • Another form of seal-forming structure may use adhesive to achieve a seal. Some patients may find it inconvenient to constantly apply and remove an adhesive to their face.
  • ResMed Limited has manufactured the following products that incorporate nasal pillows: SWIFTTM nasal pillows mask, SWIFTTM II nasal pillows mask, SWIFTTM LT nasal pillows mask, SWIFTTM FX nasal pillows mask and MIRAGE LIBERTYTM full-face mask.
  • the following patent applications, assigned to ResMed Limited, describe examples of nasal pillows masks: International Patent Application W02004/073,778 (describing amongst other things aspects of the ResMed Limited SWIFTTM nasal pillows), US Patent Application 2009/0044808 (describing amongst other things aspects of the ResMed Limited SWIFTTM LT nasal pillows); International Patent Applications WO 2005/063,328 and WO 2006/130,903 (describing amongst other things aspects of the ResMed Limited MIRAGE
  • a seal-forming structure of a patient interface used for positive air pressure therapy is subject to the corresponding force of the air pressure to disrupt a seal.
  • a variety of techniques have been used to position the seal-forming structure, and to maintain it in sealing relation with the appropriate portion of the face.
  • One technique is the use of adhesives. See for example US Patent Application Publication No. US 2010/0000534. Flowever, the use of adhesives may be uncomfortable for some.
  • Another technique is the use of one or more straps and/or stabilising harnesses. Many such harnesses suffer from being one or more of ill-fitting, bulky, uncomfortable and awkward to use.
  • a respiratory pressure therapy (RPT) device may be used individually or as part of a system to implement one or more of a number of therapies described above, such as by operating the device to generate a flow of air for delivery to an interface to the airways.
  • the flow of air may be pressurised.
  • RPT devices include a CPAP device and a ventilator.
  • Delivery of a flow of air without humidification may cause drying of airways.
  • the use of a humidifier with an RPT device and the patient interface produces humidified gas that minimizes drying of the nasal mucosa and increases patient airway comfort.
  • warm air applied generally to the face area in and about the patient interface is more comfortable than cold air.
  • Some forms of treatment systems may include a vent to allow the washout of exhaled carbon dioxide.
  • the vent may allow a flow of gas from an interior space of a patient interface, e.g., the plenum chamber, to an exterior of the patient interface, e.g., to ambient.
  • the vent may comprise an orifice and gas may flow through the orifice in use of the mask. Many such vents are noisy. Others may become blocked in use and thus provide insufficient washout. Some vents may be disruptive of the sleep of a bed partner 1100 of the patient 1000, e.g. through noise or focussed airflow.
  • ResMed Limited has developed a number of improved mask vent technologies. See International Patent Application Publication No. WO 1998/034,665; International Patent Application Publication No. WO 2000/078,381 ; US Patent No. 6,581,594; US Patent Application Publication No. US 2009/0050156; US Patent Application Publication No. 2009/0044808.
  • Polysomnography is a conventional system for diagnosis and monitoring of cardio-pulmonary disorders, and typically involves expert clinical staff to apply the system.
  • PSG typically involves the placement of 15 to 20 contact sensors on a patient in order to record various bodily signals such as electroencephalography (EEG), electrocardiography (ECG), electrooculograpy (EOG), electromyography (EMG), etc.
  • EEG electroencephalography
  • ECG electrocardiography
  • EOG electrooculograpy
  • EMG electromyography
  • PSG for sleep disordered breathing has involved two nights of observation of a patient in a clinic, one night of pure diagnosis and a second night of titration of treatment parameters by a clinician.
  • PSG is therefore expensive and inconvenient. In particular it is unsuitable for home screening / diagnosis / monitoring of sleep disordered breathing.
  • Screening and diagnosis generally describe the identification of a condition from its signs and symptoms. Screening typically gives a true / false result indicating whether or not a patient’s SDB is severe enough to warrant further investigation, while diagnosis may result in clinically actionable information.
  • Screening and diagnosis tend to be one-off processes, whereas monitoring the progress of a condition can continue indefinitely.
  • Some screening / diagnosis systems are suitable only for screening / diagnosis, whereas some may also be used for monitoring.
  • Clinical experts may be able to screen, diagnose, or monitor patients adequately based on visual observation of PSG signals. However, there are circumstances where a clinical expert may not be available, or a clinical expert may not be affordable. Different clinical experts may disagree on a patient’s condition. In addition, a given clinical expert may apply a different standard at different times.
  • the present technology is directed towards providing medical devices used in the screening, diagnosis, monitoring, amelioration, treatment, or prevention of respiratory disorders having one or more of improved comfort, cost, efficacy, ease of use and manufacturability.
  • a first aspect of the present technology relates to apparatus used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of a respiratory disorder.
  • Another aspect of the present technology relates to methods used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of a respiratory disorder.
  • An aspect of certain forms of the present technology is to provide methods and/or apparatus that improve the compliance of patients with respiratory therapy.
  • One form of the present technology comprises a patient interface for delivery of a supply of pressurised breathable gas to an entrance of a patient’s airways.
  • Another aspect of one form of the present technology is a patient interface that is moulded or otherwise constructed with a perimeter shape which is
  • An aspect of certain forms of the present technology is a medical device that is easy to use, e.g. by a person who does not have medical training, by a person who has limited dexterity, vision or by a person with limited experience in using this type of medical device.
  • An aspect of one form of the present technology is a portable RPT device that may be carried by a person, e.g., around the home of the person.
  • An aspect of the present technology relates to a patient interface including a mask assembly and a gas conduit to deliver a pressurized flow of air to the mask assembly, and the patient interface includes magnetic connector(s) to connect the conduit to the mask assembly.
  • An aspect of the present technology relates to a patient interface including a mask assembly and a pressurized gas conduit to at least partially surround the patient’s head and deliver a pressurized flow of air to the mask assembly, and the patient interface includes at least one magnetic connector to connect the conduit to the mask assembly and/or headgear.
  • An aspect of the present technology relates to a patient interface including a mask assembly and a headgear conduit to at least partially support the mask assembly on the patient’s head and deliver a pressurized flow of air to the mask assembly, and the patient interface includes magnetic connector(s) to connect the headgear conduit to the mask assembly.
  • each magnetic connector may include an opening that forms a channel through which air is directed from the conduit to the mask assembly.
  • the opening of each magnetic connector may align with a respective opening provided to the plenum chamber of the mask assembly.
  • each magnetic connector may restrict movement in one or more directions of a single plane.
  • each magnetic connector may form a sealed connection between the conduit and the mask assembly.
  • the patient interface may include plenum chamber pressurisable to a therapeutic pressure of at least 6 cmthO above ambient air pressure.
  • the plenum chamber may include a plenum chamber inlet port sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient.
  • the patient interface may include seal-forming structure constructed and arranged to form a seal with a region of the patient’s face surrounding an entrance to the patient’s airways, said seal forming structure having a hole therein such that the flow of air at said therapeutic pressure is delivered to at least an entrance to the patient’s nares.
  • the seal-forming structure may be constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient’s respiratory cycle in use.
  • the patient interface may include a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient’s head.
  • the positioning and stabilising structure may include a conduit connector assembly configured to deliver the flow of air at the therapeutic pressure.
  • the conduit connector assembly may include a connector opening.
  • the conduit connector assembly may include a connector opening.
  • the conduit connector assembly may form a tie configured to transfer tension force from the position and stabilising structure to the plenum chamber, causing the seal forming structure to press against the face of the patient.
  • the plenum chamber and the conduit connector assembly may be attracted to each other through a magnetic force.
  • a sealed connection may be formed between the plenum chamber and the conduit connector assembly such that air may be configured to pass through the connector opening and the plenum chamber inlet port.
  • the positioning and stabilising structure may include a second conduit connector assembly with a second connector opening and the plenum chamber includes a second plenum chamber inlet port, wherein the second conduit connector assembly may be configured to engage with the plenum chamber, and wherein air is configured to pass through the second connector opening and the second plenum chamber inlet port,
  • the conduit connector assembly may include a retention member receptor, the retention member receptor includes a groove for receiving a plenum magnet, wherein the plenum magnet is secured between the retention member receptor and a surface of the plenum chamber,
  • the retention member receptor may be formed of elastomeric material
  • the plenum chamber may include a retention member, wherein the retention member receptor includes an inwardly tapered outer wall, wherein retention member may be inwardly angled so as to lie flush against the inward tapered outer wall of the retention member receptor, (e) in a first orientation the conduit connector assembly may be restricted from movement by the retention member pressing against the retention member receptor in
  • the patient interface may include a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmthO above ambient air pressure, said plenum chamber including a first plenum chamber inlet port and a second plenum chamber inlet port, each being sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient.
  • the patient interface may include a seal-forming structure constructed and arranged to form a seal with a region of the patient’s face surrounding an entrance to the patient’s airways, said seal-forming structure having a hole therein such that the flow of air at said therapeutic pressure is delivered to at least an entrance to the patient’s nares.
  • the seal-forming structure may be constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient’s respiratory cycle in use.
  • the patient interface may include a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient’s head.
  • the positioning and stabilising structure may comprise a tie.
  • the tie may be constructed and arranged so that at least a portion overlies a region of the patient’s head superior to an otobasion superior of the patient’s head in use.
  • the first plenum chamber inlet port may include a first plenum chamber magnet with a first polarity and the second plenum chamber inlet port may include a second plenum chamber magnet with a second polarity.
  • the positioning and stabilising structure may include a headgear conduit for directing air to the patient’s at the therapeutic pressure.
  • the positioning and stabilising structure may comprise a first conduit connector assembly and a second conduit connector assembly.
  • the first conduit connector assembly may include a first connector magnet with the second polarity and a second connector magnet with the first polarity.
  • the first plenum chamber magnet may be attracted to the first connector magnet and the first plenum chamber magnet may repel the second connector magnet.
  • the second plenum chamber magnet may be attracted to the second connector magnet and the second plenum chamber magnet may repel the first connector magnet.
  • Air may be configured to pass from the first conduit connector assembly through the first plenum chamber inlet port and air may also be configured to pass from the second conduit connector assembly through the second plenum chamber inlet port.
  • the plenum chamber may include a first retention member receptor and a second retention member receptor
  • the first conduit connector assembly may be configured to engage with the first retention member receptor and the second conduit connector assembly configured to engage with the second retention member receptor, wherein when the first conduit connector assembly is engaged with the first retention member receptor and the second conduit connector assembly is engaged with the second retention member receptor, the plenum chamber is secured by the first conduit connector assembly and the second conduit connector assembly and is configured to receive air through the first conduit connector assembly and the second conduit connector assembly
  • the first conduit connector assembly may include a retention member, wherein the retention member may be configured to engage with a first retention member receptor of the plenum chamber such that when the retention member is engaged with the first retention member receptor of the plenum chamber the first conduit connector assembly may be restricted from laterally moving in a first direction within a plane and may be permitted to laterally move in an opposite second direction within the plane
  • the first conduit connector assembly may include a first connector opening, and when the first conduit
  • the system may comprise an RPT device and a patient interface, and an air circuit connecting the RPT device to the patient interface.
  • the RPT device may be configured to supply air at positive pressure for respiratory therapy.
  • the air circuit may be connected to the patient interface at a connection port.
  • the patient interface may include a positioning and stabilising structure and a mask assembly, the positioning and stabilising structure including a headgear conduit for receiving a therapeutic pressure of at least 6 cmthO above ambient air pressure from the air circuit, the headgear conduit extending along a crown of the patient’s head from a first parietal bone to a second parietal bone.
  • the headgear conduit may include a first end with a first conduit connector assembly.
  • the mask assembly may be
  • the mask assembly may include a plenum chamber and a seal forming structure.
  • the plenum chamber may include a plenum chamber opening sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient.
  • the plenum chamber may include a first plenum chamber receptor assembly.
  • the seal forming structure may be constructed and arranged to form a seal with a region of the patient’s face surrounding an entrance to the patient’s airways.
  • the seal forming structure may have a hole therein such that the flow of air at said therapeutic pressure is delivered to at least an entrance to the patient’s nares.
  • the seal forming structure may be constructed and arranged to maintain said therapeutic pressure in the mask assembly throughout the patient’s respiratory cycle in use.
  • the headgear conduit may be configured to deliver air through the first conduit connector assembly and through the first plenum chamber receptor assembly.
  • the first conduit connector assembly may be configured to engage with the first plenum chamber receptor assembly, and be rotatable about an axis that extends through the first plenum chamber receptor assembly. When the first conduit connector assembly is engaged with the first plenum chamber receptor assembly the first conduit connector assembly may be restricted from translating in a first direction perpendicular to the axis, and may be permitted to translate in an opposite second direction.
  • the plenum chamber and the first conduit connector assembly may be attracted to each other through a magnetic force, a seal may be formed between the plenum chamber and the first conduit connector assembly, (b) the first conduit connector assembly may include a connector opening wherein the magnetic force self-aligns the connector opening with the plenum chamber opening, (c) when the patient interface is worn by the patient the first conduit connector assembly is a tie and may provide a posterior force to the mask assembly, (d) the first conduit connector assembly may be configured to be rotatable about the first plenum chamber receptor assembly while maintaining a seal between the first conduit connector assembly and the first plenum chamber receptor assembly, (e) the headgear conduit may further comprise a second end with a second conduit connector assembly and the mask assembly may include a second plenum chamber receptor assembly, wherein the second conduit connector assembly may be configured to engage with the second plenum chamber receptor assembly, wherein air is configured to pass through the second conduit connector assembly and through the second plenum chamber
  • the patient interface may include a cushion assembly including a cushion inlet port to receive a flow of air for breathing by the patient.
  • the patient interface may include at least one inlet conduit to at least partially support and position the cushion assembly on the patient’s head.
  • the inlet conduit may be configured to deliver the pressurized flow of air to the cushion inlet port.
  • the patient interface may comprise a magnetic connector to magnetically connect the at least one inlet conduit to the cushion assembly.
  • the magnetic connector may comprise an intermediate air flow path that pneumatically connects the at least one inlet conduit to the cushion inlet port.
  • the retention member may be structured and positioned to at least partially counteract tension forces tending to separate the at least one inlet conduit from the cushion assembly, and (b) further comprising a magnetic retaining member to assist in maintaining a sealing contact between the at least one inlet conduit and the cushion inlet port.
  • the patient interface may include a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmfhO above ambient air pressure.
  • the plenum chamber may include a plenum chamber inlet port sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient.
  • the patient interface may include a seal-forming structure constructed and arranged to form a seal with a region of the patient’s face surrounding an entrance to the patient’s airways, said seal forming structure having a hole therein such that the flow of air at said therapeutic pressure is delivered to at least an entrance to the patient’s nares.
  • the seal-forming structure may be constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient’s respiratory cycle in use.
  • the patient interface may include a headgear to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient’s head.
  • the patient interface may be configured to allow the patient to breath from ambient through their mouth in the absence of a flow of pressurised air through the plenum chamber inlet port, or the patient interface may be configured to leave the patient’s mouth uncovered.
  • the patient interface may comprise a mask assembly.
  • the mask assembly may comprise a shell assembly and the seal forming structure, the plenum chamber inlet port located in the shell assembly adjacent an anchor receptor, the shell assembly being magnetized with a first polarity.
  • the headgear may include a conduit connector assembly.
  • the conduit connector assembly may include a connector opening.
  • the conduit connector assembly may be magnetized with a second polarity.
  • the conduit connector assembly may include an anchor. Tension force may be transferred from the headgear to the conduit connector assembly such that the anchor presses against the anchor receptor, causing the seal forming structure to press against the face of the patient.
  • the shell assembly and the conduit connector assembly may be attracted to each other through a magnetic force forming a seal between the shell assembly and the conduit connector assembly, and wherein air is configured to pass through the connector opening and the plenum chamber inlet port.
  • the headgear may include a second conduit connector assembly with a second connector opening and the shell assembly may include a second plenum chamber inlet port and a second anchor receptor, the second conduit connector assembly may be configured to engage with the second anchor receptor, and air may be configured to pass through the second connector opening and the second plenum chamber inlet port,
  • the anchor receptor may include a groove for receiving a shell magnet, wherein the shell magnet may be secured between the anchor receptor and a shell of the shell assembly,
  • the anchor receptor may be formed of rubber material
  • the anchor receptor may include an inwardly tapered outer wall, wherein anchor may be inwardly angled so as to lie flush against the inward tapered outer wall of the anchor receptor, (e) in a first orientation the conduit connector assembly may be restricted from movement by the anchor pressing against the anchor receptor in a first direction along a plane, and may be permitted to move in an opposite second direction along the plane in the first orientation
  • the mask assembly may be attached to the headgear
  • the patient interface may include a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmthO above ambient air pressure.
  • the plenum chamber may include a first plenum chamber inlet port and a second plenum chamber inlet port, each being sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient.
  • the patient interface may include a seal-forming structure constructed and arranged to form a seal with a region of the patient’s face surrounding an entrance to the patient’s airways.
  • the seal-forming structure may have a hole therein such that the flow of air at said therapeutic pressure is delivered to at least an entrance to the patient’s nares.
  • the seal-forming structure may be constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient’s respiratory cycle in use.
  • the patient interface may include a headgear to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient’s head.
  • the patient interface may be configured to allow the patient to breath from ambient through their mouth in the absence of a flow of pressurised air through the first plenum chamber inlet port or second plenum chamber inlet port, or the patient interface may be configured to leave the patient’s mouth uncovered.
  • the first plenum chamber inlet port may include a first shell magnet with a first polarity and the second plenum chamber inlet port may include a second shell magnet with a second polarity.
  • the headgear may include a headgear conduit for directing air to the patient’s airways.
  • the headgear may comprise a first conduit connector assembly and a second conduit connector assembly.
  • the first conduit connector assembly may include a first connector magnet with the second polarity and a second connector magnet with the first polarity.
  • the first shell magnet may be attracted to the first connector magnet and the first shell magnet may repel the second connector magnet.
  • the second shell magnet may be attracted to the second connector magnet and the second shell magnet may repel the first connector magnet.
  • Air may be configured to pass from the first conduit connector assembly through the first plenum chamber inlet port and air may also be configured to pass from the second conduit connector assembly through the second plenum chamber inlet port.
  • the plenum chamber may include a first anchor receptor and a second anchor receptor
  • the first conduit connector assembly may be configured to engage with the first anchor receptor and the second conduit connector assembly configured to engage with the second anchor receptor, wherein when the first conduit connector assembly may be engaged with the first anchor receptor and the second conduit connector assembly may be engaged with the second anchor receptor, the plenum chamber is secured by the first conduit connector assembly and the second conduit connector assembly and may be configured to receive air through the first conduit connector assembly and the second conduit connector assembly
  • the first conduit connector assembly may include an anchor, wherein the anchor is configured to engage with a first anchor receptor of the plenum chamber such that when the anchor is engaged with the first anchor receptor of the plenum chamber the first conduit connector assembly may be restricted from laterally moving in a first direction within a plane and may be permitted to laterally move in an opposite second direction within the plane
  • the first conduit connector assembly may include a first connector opening, and when the first conduit connector assembly is arranged against the plenum chamber the first conduit connector assembly
  • the system may comprise an RPT device and a patient interface, and an air circuit connecting the RPT device to the patient interface.
  • the RPT device may be configured to supply air at positive pressure for respiratory therapy.
  • the air circuit may be connected to the patient interface at a connection port.
  • the patient interface may include a headgear and a mask assembly.
  • the headgear may include a headgear conduit for receiving air from the air circuit.
  • the headgear conduit may extend along a crown of the patient’s head from a first side of the parietal bone to a second side of the parietal bone.
  • the headgear conduit may include a first end with a first conduit connector assembly.
  • the mask assembly may be pressurisable to a therapeutic pressure of at least 6 cmThO above ambient air pressure.
  • the mask assembly may include a shell assembly and a seal forming structure.
  • the shell assembly may include a shell opening sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient.
  • the shell assembly may include a first shell receptor assembly.
  • the seal forming structure may be constructed and arranged to form a seal with a region of the patient’s face surrounding an entrance to the patient’s airways.
  • the seal forming structure may have a hole therein such that the flow of air at said therapeutic pressure is delivered to at least an entrance to the patient’s nares.
  • the seal forming structure may be constructed and arranged to maintain said therapeutic pressure in the mask assembly throughout the patient’s respiratory cycle in use.
  • the headgear conduit may be configured to deliver air through the first conduit connector assembly and through the first shell receptor assembly.
  • the first conduit connector assembly may be configured to engage with the first shell receptor assembly and may be rotatable about an axis that extends through the shell receptor assembly. When the first conduit connector assembly is engaged with the first shell receptor assembly the first conduit connector assembly may be restricted from translating in a first direction perpendicular to the axis, and may be permitted to translate in an opposite second direction.
  • the shell assembly and the first conduit connector assembly may be attracted to each other through a magnetic force forming a seal between the shell assembly and the first conduit connector assembly
  • the first conduit connector assembly may include a connector opening wherein the magnetic force self-aligns the connector opening with the shell opening
  • the first conduit connector assembly may be configured to be rotatable about the first shell receptor assembly while maintaining a seal between the first conduit connector assembly and the first shell receptor assembly
  • the headgear conduit may further comprise a second end with a second conduit connector assembly and the mask assembly may include a second shell receptor assembly, wherein the second conduit connector assembly may be configured to engage with the second shell receptor assembly, wherein air is configured to pass through the second conduit connector assembly and through the second shell receptor assembly
  • the first conduit connector assembly may include an anchor, and wherein the first shell receptor assembly includes a tapered
  • the patient interface may comprise a cushion assembly including a cushion inlet port to receive a flow of air for breathing by the patient.
  • the patient interface may comprise least one inlet conduit to at least partially support and position the cushion on the patient’s head, the inlet conduit being configured to deliver the pressurized flow of air to the inlet port.
  • the patient interface may comprise a magnetic connector to magnetically connect the at least one inlet conduit to the cushion assembly.
  • the magnetic connector may comprise an intermediate air flow path that pneumatically connects the at least one air inlet conduit to the cushion inlet port.
  • the patient interface may further include (a) an anchor member that detachably interfaces with the cushion assembly, the anchor member may be structured and positioned to at least partially counteract tension forces tending to separate the at least one conduit from the cushion assembly, and/or (b) a magnetic retaining member to assist in maintaining a sealing contact between the at least one inlet conduit and the inlet port.
  • portions of the aspects may form sub-aspects of the present technology.
  • various ones of the sub-aspects and/or aspects may be combined in various manners and also constitute additional aspects or sub-aspects of the present technology.
  • Fig. 1A shows a system including a patient 1000 wearing a patient interface 3000, in the form of nasal pillows, receiving a supply of air at positive pressure from an RPT device 4000. Air from the RPT device 4000 is humidified in a humidifier 5000, and passes along an air circuit 4170 to the patient 1000. A bed partner 1100 is also shown. The patient is sleeping in a supine sleeping position.
  • Fig. IB shows a system including a patient 1000 wearing a patient interface 3000, in the form of a nasal mask, receiving a supply of air at positive pressure from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000, and passes along an air circuit 4170 to the patient 1000.
  • Fig. 1C shows a system including a patient 1000 wearing a patient interface 3000, in the form of a full-face mask, receiving a supply of air at positive pressure from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000, and passes along an air circuit 4170 to the patient 1000. The patient is sleeping in a side sleeping position.
  • Fig. 2A shows an overview of a human respiratory system including the nasal and oral cavities, the larynx, vocal folds, oesophagus, trachea, bronchus, lung, alveolar sacs, heart and diaphragm.
  • Fig. 2B shows a view of a human upper airway including the nasal cavity, nasal bone, lateral nasal cartilage, greater alar cartilage, nostril, lip superior, lip inferior, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal folds, oesophagus and trachea.
  • Fig. 2C is a front view of a face with several features of surface anatomy identified including the lip superior, upper vermilion, lower vermilion, lip inferior, mouth width, endocanthion, a nasal ala, nasolabial sulcus and cheilion. Also indicated are the directions superior, inferior, radially inward and radially outward.
  • Fig. 2D is a side view of a head with several features of surface anatomy identified including glabella, sellion, pronasale, subnasale, lip superior, lip inferior, supramenton, nasal ridge, alar crest point, otobasion superior and otobasion inferior. Also indicated are the directions superior & inferior, and anterior & posterior.
  • Fig. 2E is a further side view of a head.
  • the approximate locations of the Frankfort horizontal and nasolabial angle are indicated.
  • the coronal plane is also indicated.
  • Fig. 2F shows a base view of a nose with several features identified including naso-labial sulcus, lip inferior, upper Vermilion, naris, subnasale, columella, pronasale, the major axis of a naris and the midsagittal plane.
  • Fig. 2G shows a side view of the superficial features of a nose.
  • Fig. 2H shows subcutaneal structures of the nose, including lateral cartilage, septum cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla and fibrofatty tissue.
  • Fig. 21 shows a medial dissection of a nose, approximately several millimeters from the midsagittal plane, amongst other things showing the septum cartilage and medial crus of greater alar cartilage.
  • Fig. 2J shows a front view of the bones of a skull including the frontal, nasal and zygomatic bones. Nasal concha are indicated, as are the maxilla, and mandible.
  • Fig. 2K shows a lateral view of a skull with the outline of the surface of a head, as well as several muscles.
  • the following bones are shown: frontal, sphenoid, nasal, zygomatic, maxilla, mandible, parietal, temporal and occipital. The mental protuberance is indicated.
  • the following muscles are shown: digastricus, masseter, sternocleidomastoid and trapezius.
  • Fig. 2L shows an anterolateral view of a nose.
  • FIG. 3 A shows a patient interface in the form of a nasal mask in accordance with one form of the present technology.
  • Fig. 3B shows a schematic of a cross-section through a structure at a point. An outward normal at the point is indicated. The curvature at the point has a positive sign, and a relatively large magnitude when compared to the magnitude of the curvature shown in Fig. 3C.
  • Fig. 3C shows a schematic of a cross-section through a structure at a point. An outward normal at the point is indicated. The curvature at the point has a positive sign, and a relatively small magnitude when compared to the magnitude of the curvature shown in Fig. 3B.
  • Fig. 3D shows a schematic of a cross-section through a structure at a point. An outward normal at the point is indicated. The curvature at the point has a value of zero.
  • Fig. 3E shows a schematic of a cross-section through a structure at a point. An outward normal at the point is indicated. The curvature at the point has a negative sign, and a relatively small magnitude when compared to the magnitude of the curvature shown in Fig. 3F.
  • Fig. 3F shows a schematic of a cross-section through a structure at a point. An outward normal at the point is indicated. The curvature at the point has a negative sign, and a relatively large magnitude when compared to the magnitude of the curvature shown in Fig. 3E.
  • Fig. 3G shows a cushion for a mask that includes two pillows. An exterior surface of the cushion is indicated. An edge of the surface is indicated. Dome and saddle regions are indicated.
  • Fig. 3H shows a cushion for a mask. An exterior surface of the cushion is indicated. An edge of the surface is indicated. A path on the surface between points A and B is indicated. A straight line distance between A and B is indicated. Two saddle regions and a dome region are indicated.
  • Fig. 31 shows the surface of a structure, with a one dimensional hole in the surface.
  • the illustrated plane curve forms the boundary of a one dimensional hole.
  • Fig. 3J shows a cross-section through the structure of Fig.3I.
  • the illustrated surface bounds a two dimensional hole in the structure of Fig. 31.
  • Fig. 3K shows a perspective view of the structure of Fig. 31, including the two dimensional hole and the one dimensional hole. Also shown is the surface that bounds a two dimensional hole in the structure of Fig. 31.
  • Fig. 3L shows a mask having an inflatable bladder as a cushion.
  • Fig. 3M shows a cross-section through the mask of Fig. 3L, and shows the interior surface of the bladder. The interior surface bounds the two dimensional hole in the mask.
  • Fig. 3N shows a further cross-section through the mask of Fig. 3L. The interior surface is also indicated.
  • Fig. 30 illustrates a left-hand rule.
  • Fig. 3P illustrates a right-hand rule.
  • Fig. 3Q shows a left ear, including the left ear helix.
  • Fig. 3R shows a right ear, including the right ear helix.
  • Fig. 3S shows a right-hand helix.
  • Fig. 3T shows a view of a mask, including the sign of the torsion of the space curve defined by the edge of the sealing membrane in different regions of the mask.
  • Fig. 3U shows a view of a plenum chamber 3200 showing a sagittal plane and a mid-contact plane.
  • Fig. 3V shows a view of a posterior of the plenum chamber of Fig. 3U.
  • the direction of the view is normal to the mid-contact plane.
  • the sagittal plane in Fig. 3 V bisects the plenum chamber into left-hand and right-hand sides.
  • Fig. 3W shows a cross-section through the plenum chamber of Fig. 3V, the cross-section being taken at the sagittal plane shown in Fig. 3V.
  • A‘mid-contact’ plane is shown.
  • the mid-contact plane is perpendicular to the sagittal plane.
  • the orientation of the mid-contact plane corresponds to the orientation of a chord 3210 which lies on the sagittal plane and just touches the cushion of the plenum chamber at two points on the sagittal plane: a superior point 3220 and an inferior point 3230.
  • the mid-contact plane may be a tangent at both the superior and inferior points.
  • FIG. 3X shows the plenum chamber 3200 of Fig. 3U in position for use on a face.
  • the sagittal plane of the plenum chamber 3200 generally coincides with the midsagittal plane of the face when the plenum chamber is in position for use.
  • the mid-contact plane corresponds generally to the‘plane of the face’ when the plenum chamber is in position for use.
  • the plenum chamber 3200 is that of a nasal mask, and the superior point 3220 sits approximately on the sellion, while the inferior point 3230 sits on the lip superior.
  • Fig. 4A shows an RPT device in accordance with one form of the present technology.
  • Fig. 4B is a schematic diagram of the pneumatic path of an RPT device in accordance with one form of the present technology.
  • the directions of upstream and downstream are indicated with reference to the blower and the patient interface.
  • the blower is defined to be upstream of the patient interface and the patient interface is defined to be downstream of the blower, regardless of the actual flow direction at any particular moment. Items which are located within the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface.
  • Fig. 4C is a schematic diagram of the electrical components of an RPT device in accordance with one form of the present technology.
  • Fig. 5 A shows an isometric view of a humidifier in accordance with one form of the present technology.
  • FIG. 5B shows an isometric view of a humidifier in accordance with one form of the present technology, showing a humidifier reservoir 5110 removed from the humidifier reservoir dock 5130.
  • Fig. 6 is an alternate form of the present technology positioned on a patient’s head.
  • Fig. 7 is an isometric view of a mask assembly of the present technology.
  • Fig. 8 is a view of a shell assembly along with conduit connector assemblies.
  • FIG. 9 is an isometric view of a conduit connector assembly spaced from the shell assembly.
  • Fig. 10 is a cross-sectional view of the conduit connector assemblies and the shell assembly.
  • FIG. 11 is a cross-sectional view of the conduit connector assemblies and the shell assembly.
  • Fig. 12 is an isomeric cross-section view of the conduit connector assemblies and the shell assembly.
  • Fig. 13 is an alternate form of the present technology including an alignment and receptor feature.
  • Fig. 14 is an isometric exploded view of the shell assembly and conduit connector assembly.
  • Fig. 15 is an isometric view of the shell.
  • Fig. 16 is an isometric view of the shell magnet carrier.
  • Fig. 17 is a side view of the shell magnet carrier.
  • Fig. 18 is an isometric view of the shell magnet carrier.
  • Fig. 19 is a side view of the conduit magnet carrier.
  • Fig. 20 is an isometric view of the conduit magnet carrier.
  • Fig. 21 is an isometric view of the conduit magnet carrier.
  • Fig. 22 is an isometric view of the connector.
  • Fig. 23 is a side view of the connector.
  • Fig. 24 is an isometric view of the connector.
  • Fig. 25 is a cross-sectional view of a form of the present technology including add-on seals.
  • Fig. 26 is a cross-sectional view of a form of the present technology including overmold seals.
  • Fig. 27 is an isometric view of an alternate form of the present technology.
  • Fig. 28 is a side view of an alternative form of the present technology.
  • the present technology comprises a method for treating a respiratory disorder comprising the step of applying positive pressure to the entrance of the airways of a patient 1000.
  • a supply of air at positive pressure is provided to the nasal passages of the patient via one or both nares.
  • mouth breathing is limited, restricted or prevented.
  • the present technology comprises an apparatus or device for treating a respiratory disorder.
  • the apparatus or device may comprise an RPT device 4000 for supplying pressurised air to the patient 1000 via an air circuit 4170 to a patient interface 3000.
  • a non-invasive patient interface 3000 in accordance with one aspect of the present technology comprises the following functional aspects: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilising structure 3300, a vent 3400, one form of connection port 3600 for connection to air circuit 4170, and a forehead support 3700.
  • a functional aspect may be provided by one or more physical components.
  • one physical component may provide one or more functional aspects.
  • the seal-forming structure 3100 is arranged to surround an entrance to the airways of the patient so as to facilitate the supply of air at positive pressure to the airways.
  • a patient interface is unable to comfortably deliver a minimum level of positive pressure to the airways, the patient interface may be unsuitable for respiratory pressure therapy.
  • the patient interface 3000 in accordance with one form of the present technology is constructed and arranged to be able to provide a supply of air at a positive pressure of at least 6 cmThO with respect to ambient.
  • the patient interface 3000 in accordance with one form of the present technology is constructed and arranged to be able to provide a supply of air at a positive pressure of at least 10 cmfhO with respect to ambient.
  • the patient interface 3000 in accordance with one form of the present technology is constructed and arranged to be able to provide a supply of air at a positive pressure of at least 20 cmfhO with respect to ambient.
  • a seal-forming structure 3100 provides a target seal-forming region, and may additionally provide a cushioning function.
  • the target seal-forming region is a region on the seal-forming structure 3100 where sealing may occur.
  • the region where sealing actually occurs- the actual sealing surface- may change within a given treatment session, from day to day, and from patient to patient, depending on a range of factors including for example, where the patient interface was placed on the face, tension in the positioning and stabilising structure and the shape of a patient’s face.
  • the target seal-forming region is located on an outside surface of the seal-forming structure 3100.
  • the seal-forming structure 3100 is constructed from a biocompatible material, e.g. silicone rubber.
  • a seal-forming structure 3100 in accordance with the present technology may be constructed from a soft, flexible, resilient material such as silicone.
  • a system comprising more than one a seal-forming structure 3100, each being configured to correspond to a different size and/or shape range.
  • the system may comprise one form of a seal-forming structure 3100 suitable for a large sized head, but not a small sized head and another suitable for a small sized head, but not a large sized head.
  • a mask assembly and the air delivery conduit are removably attachable to each other.
  • the mask assembly may include the seal forming structure.
  • the seal-forming structure is removable from the rest of the mask assembly in a non-destructive way.
  • the mask assembly and the air delivery conduit may interact to form a passageway through which air is delivered to the patient.
  • the arrangement may also include a vent to allow the washout of exhaled carbon dioxide.
  • a seal is formed between the seal forming structure and a region of the patient’ s face surrounding an entrance to the patient’s airways.
  • the seal forming structure tends to push away from the patients face and thus an opposite force is applied to the seal forming structure to assist in maintaining its position with respect the patient’s face, surround the entrance to the patient’s airways.
  • patients may also desire a patient interface that is easily removable.
  • a patient interface that integrates a structure configured to stabilise and maintain sufficient force with an air delivery conduit may reduce the complexity of securing the patient interface to a patient such patient compliance with therapy is increased. A patient interface with such an arrangement is discussed below.
  • Patient interface 6000 includes a positioning and stabilizing structure that includes headgear 6300 and a mask assembly 6050, also referred to as a cushion assembly.
  • Mask assembly 6050 may include various components including seal forming structure 6100 (sometimes referred to as a cushion), shell assembly 6200 and other components such as attachment components or ventilation components (see Fig. 3A).
  • a chamber may be formed when combining seal forming structure 6100 with shell 6220. Therefore, each of shell 6220 and seal forming structure 6100 may form a portion of the plenum chamber. This plenum chamber is configured to be pressurisable to a therapeutic pressure of at least 6 cmFbO above ambient air pressure.
  • the plenum chamber and seal forming structure 6100 may be a unitary member. In other forms the plenum chamber and seal forming structure 6100 may be formed of the same material. In still further forms, mask assembly 6050 may not include a separate shell 6220, rather components may be secured to the plenum chamber.
  • the plenum chamber may comprise shell 6220 or shell assembly 6200. Further, in this detailed description a separate shell and shell assembly are described, however, in other forms the plenum chamber may not include a separate distinguishable shell assembly.
  • the components that are described as being attached to the shell may be co-formed with the plenum chamber or may also be attached to the plenum chamber. Further, the plenum chamber may include a seal forming structure or may be co-formed with the seal forming structure.
  • Fleadgear 6300 may be positioned to pass over a crown of a patient’s head along the parietal bones from a left side to a right side of the patient’s head.
  • Headgear 6300 may include a headgear conduit 6302 that receives air that passes from RPT device 4000 through air circuit 4170 and through connection port 6600.
  • Headgear 6300 includes a first conduit extension 6306 and second conduit extension 6308. These extensions extend toward and connect with mask assembly 6050 and terminate at respective ends.
  • First conduit extension 6306 and second conduit extension 6308 may be configured to transfer a force from headgear 6300, for example force 6309, to maintain mask assembly 6050 in position.
  • the force applied to mask assembly 6050 may be a force vector in the appropriate direction and magnitude to provide an adequate seal between seal forming structure 6100 and the patient’s face.
  • first conduit extension 6306 and second conduit extension 6308 may form ties that transfer tension forces to the mask assembly.
  • First conduit extension 6306 and second conduit extension 6308 may be utilized draw seal-forming structure 6100 into sealing contact with a portion of the patient’s face.
  • first conduit extension 6306 and second conduit extension 6308 may be conduits such that each is configured to deliver air to the patient 1000. Therefore, first conduit extension 6306 and second conduit extension 6308 of headgear conduit 6302 may be configured to provide a supporting force to mask assembly 6050, deliver air to patient 1000, and draw seal-forming structure 6100 into sealing contact with a portion of the patient’s face. In some forms, no additional portions of headgear 6300 are configured to interact with mask assembly 6050. That is, only first conduit extension 6306 and second conduit extension 6308 connect to mask assembly 6050.
  • conduit connector assembly 6310 may be configured in use to be in tension and to direct a force to draw seal forming structure 6100 into contact with a portion of the patient’s face.
  • Other portions of headgear 6300 may also be in tension and form ties to assist in drawing seal forming structure 6100 into contact with a portion of the patient’s face.
  • headgear 6300 may comprise additional straps configured to position the patient interface 6000 about the patient’ s head to provide an adequate seal between seal forming structure 6100 and the patient while also permitting a comfortable fit of patient interface 6000.
  • a strap may be utilized that passes along the occipital bone of the patient and attaches to headgear conduit 6302.
  • mask assembly 6050 may include retainer features that secure mask assembly 6050 to headgear 6300.
  • mask assembly 6050 may include hooks or openings through which additional straps of headgear 6300 may pass to secure headgear 6300 to mask assembly 6050.
  • patient interface 6000 may include other mask assemblies or cushion assemblies such as the nasal mask depicted in Fig. 1B or the full face mask depicted in Fig. 1C.
  • mask assembly 6050 is shown in isolation from the rest of patient interface 6000.
  • shell assembly 6200 interacts with and secures seal forming structure 6100.
  • mask assembly 6050 may not include a separate shell assembly but rather may include a plenum chamber.
  • the shell assembly may form a portion of plenum chamber, or a shell may not be included in the plenum chamber.
  • the plenum chamber may be integrally formed with the sealing forming structure.
  • a tab from seal forming structure 6100 corresponds with a slot 6222 in shell assembly 6200 such that the tab is configured to maintain a friction fit with shell assembly 6200.
  • seal forming structure 6100 is configured to protrude into a corresponding circumferential channel or groove 6224 (See Fig. 5) of shell assembly 6200 such that seal forming structure 6100 is secured with shell assembly 6200.
  • seal forming structure 6100 may be permanently secured with shell assembly 6200 such as by adhesive or co-molding or co-forming.
  • seal forming structure 6100 may be friction or snap fit with shell assembly 6200 such that seal forming structure 6100 is non-destructively removable from shell assembly 6200.
  • seal forming structure 6100 may be removable such that the patient is able to clean seal forming structure 6100 or replace seal forming structure 6100 when required.
  • mask assembly 6050 is a separate component from the rest of patient interface 6000. That is, mask assembly 6050 may be non-destructively removable from the other components of patient interface 6000.
  • mask assembly 6050 may be secured to headgear 6300 only via a connection pathway as discussed later in this detailed description. That is, no additional straps may be required to secure mask assembly 6050 beyond the air conduit connection between mask assembly 6050 and headgear conduit 6302. In other forms, however, additional straps may be utilized to secure mask assembly 6050 in place during use.
  • shell assembly 6200 includes shell opening 6212, also referred to as a plenum inlet port, and second shell opening 6216.
  • Shell opening 6212 is bounded by a shell magnet carrier 6214 and shell opening 6216 is similarly bounded by second shell magnet carrier 6215.
  • a plenum magnet carrier may be utilized and secured to the plenum chamber or co-formed with the plenum chamber.
  • the plenum magnet carrier may also be utilized as a retention member.
  • a separate retention member may be utilized that does not house a magnet.
  • the retention member may be integrally formed with the plenum chamber. In other forms the retention member may be separately formed.
  • the shell magnet carriers may be substantially cylindrical in shape and the shape of the shell magnet carriers are shown in detail in Figs. 16-18. These magnet carriers are utilized to secure magnets in place while also protecting the magnets from damage.
  • shell magnet carrier 6214 secures shell magnet 6218.
  • the magnet carriers also are utilized to assist in securing headgear 6300 to mask assembly 6050 by providing an engagement feature, retention member receptor, lip, edge, prong, pin, or anchor receptor to which portions of a conduit connector assembly 6310 may interact.
  • the combination of shell magnet carrier 6214 and shell magnet 6218 is referred to as shell receptor assembly 6230 or in other forms a plenum chamber receptor.
  • the inlet port may be magnetized without the use of a shell magnet carrier or other carrier.
  • a receptor assembly may be spaced from the inlet port.
  • the inlet port and the receptor may be formed as a unitary piece or a single component.
  • a separate component may be utilized to interact with the conduit connector assembly 6310.
  • a magnet may be enclosed in shell magnet carrier 6214 however a separate anchor receptor may be utilized to interact with a corresponding anchor of conduit connector assembly 6310.
  • the anchor receptor may be spaced from the shell openings and/or the shell magnet carriers.
  • the anchor may also be utilized to restrict or reduce rotational movement of the conduit connector assembly 6310.
  • conduit connector assembly 6310 is utilized to secure the ends of headgear 6300 to shell assembly 6200 such that the interiors of mask assembly 6050 and headgear conduit 6302 (see Figs. 6 and 11) are in fluid communication with each other thereby forming a pneumatic connection.
  • connector opening 6312 aligns with shell opening 6212. This connection permits air to flow through connector opening 6312 and shell opening 6212 to the patient such that the patient is able to receive therapy.
  • Conduit connector assembly 6310 may assist in providing an air tight seal between mask assembly 6050 and headgear conduit 6302 to minimize the quantity of air leakage through the junction between the components. As shown in Fig. 8 as well as Figs. 9-14, conduit connector assembly 6310 is depicted without the rest of headgear 6300 for ease of viewing. Further, shell assembly 6200 is depicted without seal forming structure 6100 for ease of viewing and description. It should be recognized that in use conduit connector assembly 6310 is secured to headgear 6300 and/or headgear conduit 6302 and seal forming structure 6100 is secured to shell assembly 6200.
  • conduit connector assembly 6310 includes a connector opening 6312.
  • This connector opening 6312 corresponds with a shell opening 6212.
  • the openings are aligned with each other and form a channel through which air is directed from headgear conduit 6302 to mask assembly 6050 (see for example Fig. 10 and Fig. 11).
  • the shell assembly 6200 includes two openings (shell opening 6212 and second shell opening 6216) on opposite sides of shell assembly 6200. Each of these openings may be utilized to direct air toward a naris of the patient.
  • shell assembly 6200 and conduit connector assembly 6310 are depicted in cross-section. In Fig.
  • conduit connector assembly 6310 is removably secured to shell assembly 6200.
  • a magnetic attraction between the conduit connector assembly 6310 and the shell assembly 6200 allows the connectors to easily self-locate towards one another for magnetic engagement. This self-location or self-alignment may assist in locating other portions of headgear 6300 in a position to assist in maintaining seal forming structure 6100 contact with the patient’s face.
  • the magnetic attraction also allows the conduit connector assembly 6310 to self-connect to the shell assembly 6200 or self-align with the shell assembly 6200.
  • conduit connector assembly 6310 may be removed from shell assembly 6200 simply by pulling conduit connector assembly 6310 in a particular direction away from shell assembly 6200. No pinching of tabs or twisting to disengage is required. This easily removable and attachable feature may be attractive to patients that have difficulty removing and donning a patient interface.
  • conduit connector assembly 6310 may be permitted to freely rotate about the axis A that extends through the center of shell opening 6312 as well as connector opening 6312. Permitting conduit connector assembly 6310 to rotate may permit patient interface 6000 to be usable with a multitude of differently shaped heads and face of patients. Additionally, the ability to rotate the conduit connector assembly 6310 provides the ability to adjust the orientation of the extensions 6306 and 6308 with respect to the mask assembly 6050 such that the force vectors provided by said extensions 6306 and 6308 may be adjusted.
  • freely rotate is used to relate to forms in which protrusions, snaps, or locks between shell assembly 6200 and conduit connector assembly 6310 do not restrain the rotation of conduit connector assembly 6310 about an axis. As shown in Fig. 8, when conduit connector assembly 6310 is positioned against or engaged with shell receptor assembly 6230 conduit connector assembly 6310 is still permitted to rotate about the axis A.
  • magnets may not be utilized. In other forms, magnets may be used in on area while a ferrous material may be used in another to form a magnetic attraction such that each portion need not include a magnet to form a magnetic attraction.
  • conduit connector assembly 6310 may include a magnet while shell assembly 6200 include a ferrous material.
  • conduit connector assembly 6310 includes a magnet with north polarity and shell receptor assembly 6230 includes a ferrous material.
  • Conduit connector assembly 6311 may include a ferrous material while second shell magnet 6228 is north in polarity.
  • conduit connector assembly 6310 and conduit connector assembly 6311 may be restricted from connecting to the incorrect opening within the plenum chamber or shell assembly 6200.
  • conduit connector assembly 6310 and the shell receptor assembly 6230 causes conduit connector assembly 6310 and the shell receptor assembly 6230 to be attracted to each other such that a seal is formed between conduit connector assembly 6310 and shell receptor assembly 6230.
  • This may form a pneumatic seal between the mask assembly 6050 and the headgear conduit 6302.
  • This may be a separate function from the self- locating feature.
  • conduit connector assembly 6310 and shell receptor assembly 6230 may be particularly oriented by the user or a clip or other mechanism and the magnetic form may be utilized to provide the seal between the components.
  • the magnetic force may self-align the conduit connector assembly 6310 to the shell assembly 6200, thereby positioning the conduit connector assembly 6310 and shell assembly 6200 in a particular orientation to assist in donning patient interface 6000.
  • a separate action or structure may provide a seal between the conduit connector assembly and the shell assembly 6200.
  • a separate snap, clip, slide, pressure fit connection, or other suitable connection may be formed separately from the magnetic force. In such a configuration the magnetic force may still be utilized to located the various components of patient interface 6000 in a suitable position to permit adequate use of patient interface 6000.
  • mask assembly 6050 When worn by a patient, mask assembly 6050 may be disposed to fall away from the face. That is, in the anterior and/or inferior direction (see e.g., Fig.
  • Headgear 6300 meanwhile may be configured to support mask assembly 6050 by providing an opposite posterior and/or superior force to mask assembly 6050.
  • the configuration of conduit connector assembly 6310, conduit connector assembly 6311, and mask assembly 6050 utilizes these forces so that each of the mask assembly 6050, conduit connector assembly 6310, and conduit connector assembly 6311 position and stabilise mask assembly 6050 in place.
  • connector 6316 of conduit connector assembly 6310 includes a front lip 6314. This front lip 6314 extends around and abuts against the shell magnet carrier 6214 such that the front lip 6314 is anchored to shell magnet carrier 6214.
  • front lip 6314 or a portion of conduit connector assembly 6310 that restrictively engages with a portion of shell assembly 6200 may be referred to as an anchor or anchor member.
  • This anchor member may be structured and positioned to at least partially counteract tension forces tending to separate the shell assembly 6200 from the conduit connector assembly 6310.
  • the outer surface of the shell magnet carrier 6214 has a tapered surface and the front lip 6314 of the connector 6316 has an oppositely angled interior surface such that the interior surface of front lip 6314 lies flush against the outer surface of shell magnet carrier 6214.
  • the interior surface of front lip 6314 may be substantially linear along the height of front lip 6314.
  • shell magnet carrier 6214 permits front lip 6314 to“hook” or grab against shell magnet carrier 6214 when the front lip 6314 is placed in tension against shell magnet carrier 6214 while also permitting rotation about Axis A. This tension assists in pressing the seal forming structure 6100 to the face of the patient to form a seal. Because connector 6316 is in tension T (see Fig. 10) generally toward the face of the patient (or posterior direction), and mask assembly 6050 is disposed to fall away from the face (or anterior direction) the front lip 6314 and shell magnet carrier 6214 work to maintain mask assembly 6050 in a stable location. As previously described, an anchor receptor may be utilized that is spaced from shell magnet carrier 6214. In such configurations the front lip 6314 or anchor of conduit connector assembly 6310 may interact with the anchor receptor.
  • the shell magnet carrier 6214 or other retention member receptor may have variously shaped outer walls.
  • the retention member receptor may have a flat outer wall that does not taper but rather stays consistent along the height of the retention member receptor such that the retention member receptor is cylindrical rather than conical.
  • the retention member receptor may have a rounded outer surface or may include a concave inward or concave outward surface.
  • a retention member may have an oppositely shaped surface, or surface with the opposite curvature from the retention member receptor such that the surfaces of the retention member receptor and the retention member lie flush against one another when positioned adjacent to each other during use.
  • an anchor or anchor receptor may have a male or female configuration.
  • the anchor need not be at an end of conduit connector assembly 6310.
  • conduit connector assembly 6310 may have a separate opening spaced from connector opening 6312 that is configured to receive a corresponding anchor receptor located on shell assembly 6200. In such a manner the anchor and anchor receptors may be spaced from the pneumatic seals as well as the magnets of patient interface 6000.
  • connector 6316 is in tension toward the face of the patient during use of patient interface 6000, there is no need to secure connector 6316 to maintain force away from the face of the patient.
  • the front lip 6314 does not extend all around the perimeter of connector 6316.
  • this design permits connector 6316 to move away from the face (or the anterior direction). By moving the connector 6316 in the anterior direction, the front lip is moved away from the shell magnet carrier 6214 and the conduit connector assembly 6310 is able to be removed from mask assembly 6050. In this manner, the conduit connection may act as both a support for mask assembly 6050 as well as an easily removable air passage conduit.
  • conduit connector assembly 6310 may include an annular extension that extends into shell opening 6212. The extension may abut against the interior surfaces that bound shell opening 6212 such that conduit connector assembly 6310 is restrained from lateral translation, but would permit movement of the conduit connector assembly 6310 into and out of the shell opening 6212.
  • front lip 6314 (see Figs. 10 and 22) along with upper and lower lips 6330, 6332 (see Figs. 12 and 22), assist in restraining conduit connector assembly 6310 from moving outward from the sagittal plane along directions 6097, 6098, and 6099.
  • the lips do not resist movement in laterally inward toward the sagittal plane along direction 6399. This permits removal of conduit connector assembly 6310 by moving conduit connector assembly in direction 6399.
  • conduit connector assembly 6310 is restricted from moving laterally in the plane that includes direction 6097, 6098, and 6099.
  • conduit connector assembly 6310 is able to move in direction 6399 which is in the same plane direction 6098, but in an opposite direction. Therefore conduit connector assembly 6310 is restricted from moving in various directions of a single plane, however conduit connector assembly 6310 may move in a particular direction within the plane. As depicted, conduit connector assembly 6310 is able to be moved in a direction opposite of the direction of force applied upon connector assembly 6310 by headgear 6300.
  • conduit connector assembly 6310 Based on the design of conduit connector assembly 6310 and in particular the interaction between connector 6316 and shell magnet carrier 6214, removal of conduit connector assembly 6310 from shell assembly 6200 may be more particular than just an anterior movement by conduit connector assembly 6310. Due to the angled nature of both shell magnet carrier 6214 and front lip 6314, conduit connector assembly 6310 is moved away from shell magnet carrier 6214 in a lateral direction toward the sagittal plane or the center of shell assembly 6200. This forms a space between shell magnet carrier 6214 and front lip 6314 such that the conduit connector assembly 6310 is permitted to move in the anterior direction away from mask assembly 6050. For example, a possible removal motion is depicted in Fig. 11.
  • conduit connector assembly may first be moved laterally toward the centre of shell assembly 6200 along the direction of Fl. After movement in the direction of Fi conduit connector assembly 6310 may then be moved along the direction of F2, allowing conduit connector assembly 6310 to be moved away from mask assembly 6050.
  • a combination of forces may be utilized. For example, rather than pulling conduit connector assembly 6310 along direction F2, mask assembly 6050 may be pressed in an opposite direction toward the face of the patient, thus causing sufficient space to permit conduit connector assembly 6310 to be removed from mask assembly 6050. Further, in some forms, sufficient force along direction F 2 may press front lip 6314 against the outer surface of shell magnet carrier 6214, moving conduit connector assembly 6310 in a direction parallel to direction Fl such that conduit connector assembly 6310 is removable from shell magnet carrier 6214.
  • the magnets of the shell assembly 6200 and the magnets in the conduit connector assembly 6310 may be particularly arranged to prevent, resist, or reduce the chance of attaching the conduit connector assembly 6310 to the incorrect shell opening 6212.
  • shell assembly 6200 includes shell opening 6212 and second shell opening 6216. Each of the openings in shell assembly 6200 may be associated with an air passage for directing air toward an individual naris of the patient.
  • mask assembly 6050 may be formed so as to fit on the face of the patient in a particular orientation. For example, mask assembly 6050 may not be completely symmetrical along all axes. Therefore, there may be a “wrong” way and a“right” way to wear the patient interface 6000. For example, there may be a“left” shell opening and a“right” shell opening as well as a“left” conduit connector assembly and a“right” conduit connector assembly.
  • the magnets within each of the conduit connector assembly and the shell assembly may have particular polarities.
  • shell magnet 6218 has an outer portion (facing away from shell 6220) with a first polarity (for example, associated with the magnetic North) and an inner portion with an opposite second polarity (for example, associated with magnetic South).
  • Conduit magnet 6318 has an outer portion (facing away from connector 6316) that has a South polarity and an opposite inner portion with a North polarity.
  • second shell magnet carrier 6215 includes second shell magnet 6228.
  • Second shell magnet 6228 has an outer portion (facing away from shell 6220) with South polarity and an opposite inner portion with North polarity.
  • Second conduit magnet 6328 has an outer portion with North polarity and an inner portion with South polarity.
  • the polarity of shell magnet 6218 is in an opposite orientation from second shell magnet 6228.
  • the polarity of conduit magnet 6318 also has an opposite orientation from second conduit magnet 6328.
  • conduit connector assembly 6310 was oriented adjacent second shell magnet carrier 6215 magnetic forces between second shell magnet 6228 and conduit magnet 6318 would repel one another. That is because the South polarity portions of second shell magnet 6228 and conduit magnet 6318 would be facing one another. Therefore the arrangement of magnets within shell assembly 6200 and the conduit connector assemblies may reduce the possibility of incorrect assembly between patient interface 6000 and mask assembly 6050.
  • the configuration of as shown in Fig. 10 includes shell magnet 6218 with a consistent North polarity on the outer portion and conduit magnet 6318 with a consistent South polarity of the outer portion such that shell magnet 6218 and conduit magnet 6318 are attracted to each other.
  • the magnets are able to connect to each other at various angles.
  • conduit connector assembly 6310 may be able to rotate about Axis A and connect to shell receptor assembly 6230 at various angles.
  • conduit connector assembly 6310 and shell receptor assembly 6230 may be simply and easily connected to each other without the need to have a particular angular arrangement with respect to Axis A prior to attachment.
  • Utilizing magnets to connect shell receptor assembly 6230 and conduit connector assembly 6310 may permit self-locating between conduit connector assembly 6310 and shell receptor assembly 6230. Because the components utilize magnets, shell receptor assembly 6230 and conduit connector assembly 6310 need not be perfectly aligned. When arranged sufficiently close to each other, the magnetic forces may orient the shell receptor assembly 6230 with the conduit connector assembly 6310 without the need for the patient to particularly align the components. By increasing the ease at which the components can be connected a patient may be more inclined to where the patient interface 6000 to maintain therapy treatment.
  • conduit connector assembly 6311 is depicted in conjunction with a portion of headgear conduit 6302.
  • Headgear conduit 6302 is formed of a textile material such as a woven, non-woven, knit, braided, or any other network of fibres. Additionally, headgear conduit 6302 may be formed of a silicone, hard plastic or soft plastic, or plastic overmolded with textile or any combinations of materials. In other forms, headgear conduit 6302 may include rigid portions and floppy portions along the length of headgear conduit 6302. As depicted, headgear conduit 6302 is formed at least partially from a textile material.
  • Headgear conduit 6302 may be attached to conduit connector assembly 6311 such that air that is located within headgear conduit 6302 may pass through conduit connector assembly 6311 and to mask assembly 6050 with minimal leakage.
  • conduit connector assembly 6311 may be located substantially within headgear conduit 6302.
  • conduit connector assembly 6311 may be secured along an outer surface of headgear conduit 6302.
  • Conduit connector assembly 6311 (as well as conduit connector assembly 6310), may be secured to headgear conduit 6302 through thermoplastic, thermobonding (such as through the use of thermoset materials), as well as glue adhesive, other mechanical configurations, as well as any combination of the various securement mechanisms described above.
  • air 6304 is directed along headgear conduit 6302 and through both conduit connector assembly 6311 and shell assembly 6200.
  • the channel between mask assembly 6050 and headgear conduit 6302 may be substantially air tight to minimize the quantity of leakage of air through patient interface 6000.
  • connector 6316 includes an upper and lower lips 6330, 6332.
  • upper and lower lips 6330, 6332 may be continuous with front lip 6314.
  • upper and lower lips 6330, 6332 may be spaced from front lip 6314 such that the line on which the lips are located is discontinuous.
  • upper and lower lips 6330, 6332 engage with the outer face of shell magnet carrier 6214. In this manner, conduit connector assembly 6310 may be restricted from pulling off or moving in various direction.
  • upper and lower lips 6330, 6332 may restrict conduit connector assembly 6310 from moving upward and downward with respect to shell assembly 6200.
  • upper and lower lips 6330, 6332 the possibility of accidental removal of conduit connector assembly 6310 from shell assembly 6200 may be reduced.
  • front lip 6314 along with upper and lower lips 6330, 6332 may permit various patients to use similarly shaped patient interfaces.
  • a mask assembly such as mask assembly 6050 may conform to different patients along different planes such that the conduit connector assemblies do not always provide tension in the same direction. For example, some headgear 6300 may provide tension in a substantially anterior direction, whereas on other patients the headgear 6300 may provide tension in a more superior direction. Depending on the shape of the face, different tensions may occur. When oriented in different manners the conduit connector assemblies may rotate with respect to various patient faces. As described above, the junction between mask assembly 6050 and headgear 6300 is formed utilizing magnets.
  • the magnetic field attachment may permit the conduit connector assemblies to rotate (for example, about Axis A shown in Fig. 9) with respect to mask assembly 6050. This rotation may permit different sized and shaped faces to use the same patient interface and may also be used to adjust the orientation of first and second extensions 6306, 6308 direct the force vectors therefrom. Further, by including front lip 6314, along with upper and lower lips 6330, 6332, headgear 6300 may be able to rotate and still provide adequate and appropriate tension along different planes to mask assembly 6050.
  • conduit connector assemblies may include alignment features to secure the conduit connector assemblies in place with respect to the mask assembly.
  • conduit connector assembly 6310 includes a male alignment feature 6334.
  • Alignment feature 6334 may be various shapes including rectangular, square, trapezoidal, circular, and pyramidal or other shapes. As depicted, alignment feature 6334 is substantially cylindrical in shape. Alignment feature 6334 may be a separate component or may be integrated or formed with other components of conduit connector assembly 6310. For example, alignment feature 6334 may be integrally formed with conduit magnet carrier 6336.
  • Shell assembly 6200 may include a corresponding female receptor feature 6238.
  • Receptor feature 6238 may be formed in the negative of alignment feature 6334 so as to accept alignment feature 6334. When aligned with each other the alignment feature 6334 and receptor feature 6238 restrict the rotation of conduit connector assembly 6310 with respect to shell assembly 6200.
  • the alignment and receptor features may be offset from the center of the shell opening 6212 and the connector opening 6312. By offsetting the alignment and receptor features, accidental alignment of the incorrect conduit connector assembly may be reduced.
  • alignment feature 6334 is offset from the center of connector opening 6312 by a distance X.
  • Receptor feature 6338 is similarly offset from the center of shell opening 6212 by a distance X.
  • the opposite conduit connector assembly 6311 and second shell opening 6216 may have an oppositely arranged alignment and receptor feature such that the alignment feature 6334 would not be able to be aligned with the receptor feature around shell opening 6212. Additionally, the alignment and receptor features may be differently shaped such that a connection between incorrect receptor and alignment features would be reduced.
  • conduit connector assembly 6310 includes connector 6316, conduit magnet 6318 and conduit magnet carrier 6336.
  • Connector 6316 includes a raised platform 6340 (see Fig. 22) for receiving conduit magnet 6318.
  • the outer surface of raised platform 6340 may substantially correspond to the surface of conduit magnet 6318 that rests upon raised platform 6340.
  • conduit magnet 6318 may be glued or otherwise secured to raised platform 6340.
  • a raised platform may not be utilized and/or the conduit magnet may be unattached to the raised platform.
  • Conduit magnet carrier 6336 is configured to extend around and three sides of conduit magnet 6318 and form a barrier between any pass through conduit connector assembly 6310 and conduit magnet 6318.
  • conduit magnet carrier 6336 includes a channel or groove 6342 (see Fig. 20) that extends around the opening of conduit magnet carrier 6336.
  • Groove 6342 may be shaped and sized to accept conduit magnet 6318 such that conduit magnet 6318 is sandwiched between conduit magnet carrier 6336 and connector 6316. Further, when assembled with connector 6316 and conduit magnet 6318 groove 6342 may also be sufficiently deep to accommodate raised platform 6340. That is, when assembled the ends of conduit magnet carrier 6336 contact the surface of connector 6316 such that the interior surfaces of conduit magnet carrier 6336 abut against surfaces of raised platform 6340 as well as conduit magnet 6318.
  • groove 6342 may be spaced from the outer surfaces of conduit magnet 6318 and raised platform 6340 however conduit magnet carrier 6336 may seal conduit magnet 6318 and/or raised platform 6340 from air that may pass through conduit connector assembly 6310.
  • Conduit magnet carrier 6336 may be secured to connector 6316 through adhesive or other mechanism. Further, in some forms, conduit magnet 6318 may be secured to conduit magnet carrier 6336 and in other forms conduit magnet 6318 may be secured to raised platform 6340. In either form, however, conduit magnet may be located within groove 6342 of conduit magnet carrier 6336 when fully assembled.
  • Conduit magnet 6318 may be substantially ring-shaped or cylindrical shaped. As shown throughout the Figures, conduit magnet 6318 is a continuous ring. In other forms, conduit magnet 6318 may comprise multiple magnets that are oriented to attract an oppositely polarized magnet of shell assembly 6200. By utilizing a continuous cylindrical magnet, a secure or consistent connection between conduit magnet 6318 and shell magnet 6218 may be formed. That is, rather than multiple magnets that may be spaced from one another, both conduit magnet 6318 and shell magnet 6218 are formed as single components with a constant and consistent area of polarity that permits a constant and consistent connection between shell assembly 6200 and conduit connector assembly 6310.
  • Shell assembly 6200 includes shell receptor assembly 6230.
  • Shell receptor assembly 6230 includes shell magnet carrier 6214 and shell magnet 6218.
  • Shell receptor assembly 6230 may be positioned to circumscribe shell opening 6212.
  • the upper surface of raised platform 6240 may be spaced from the surrounding areas of shell assembly 6200.
  • raised platform 6240 may be formed to circumscribe shell opening 6212. Further, raised platform 6240 may be shaped to abut an inner surface of shell magnet 6218.
  • Shell magnet carrier 6214 may include a groove 6242 to accept and accommodate shell magnet 6218. Further, shell magnet carrier 6214 may also be shaped to extend around the exposed surfaces of shell magnet 6218 so as to limit the amount of air that may leak between shell magnet carrier 6214 and shell magnet 6218. As depicted for example in Fig. 10, shell magnet carrier 6214 abuts an outer surface of shell 6220. Further, the inner wall of shell magnet carrier 6214 is also configured to extend along the inner surface of raised platform 6240. As shown, raised platform 6240 bounds shell opening 6212 such that there is no shoulder beyond raised platform 6240 (in contrast to the inner shoulder of raised platform 6340). In other forms, raised platform 6240 may be similarly shaped and formed as raised platform 6340 associated with conduit connector assembly 6310.
  • shell 6220 is depicted.
  • shell 6220 may also include a vent for venting waste air away from the patient.
  • Shell 6220 includes shell opening 6212 and second shell opening 6216.
  • Shell opening 6212 is surrounded by raised platform 6240.
  • Raised platform 6240 may be integrally formed with the rest of shell 6220 or may be separately attached.
  • Shell channel 6244 is a depression within shell 6220 that completely surrounds raised platform 6240.
  • Shell channel 6244 may be shaped to accept a portion of shell magnet carrier 6214.
  • raised platform 6240 may restrict the lateral motion of shell magnet carrier 6214.
  • Central portion 6246 may be a partially curved section such that shell opening 6212 and second shell opening 6216 are oriented in different planes.
  • Shell 6220 may be formed in various configuration and shapes. For example, in other forms a nasal mask, or full face mask shell may be utilized.
  • shell 6220 Various types of materials may be utilized for shell 6220.
  • a hard plastic material such as a polycarbonate may be utilized.
  • Forming shell 6220 of a polycarbonate material may provide sufficient rigidity for use with a
  • shell 6220 may be able to maintain the shape of seal forming structure 6100 in the areas that shell 6220 interacts with seal forming structure 6100 so that a consistent seal is formed between sealing forming structure 6100 and the patient.
  • thermoplastic materials, thermoset materials, metal materials, woven and non-woven materials, in addition to rubber or elastomeric materials may be utilized to form shell 6220.
  • shell 6220 may be formed of a metal material or contain ferrite or carbon material. In such forms, shell 6220 may permit attraction from with conduit connector assembly 6310 or conduit connector assembly 6311. In some forms, rather than including a separate magnet component such as shell magnet 6218 and shell magnet carrier 6214, shell 6220 may be formed of a magnetic or metal material. Further, the shell 6220 may be overlaid with a seal or o-ring or other sealing mechanism to provide an air flow path between conduit connector assembly 6310 and shell 6220. Additionally, the other components such as conduit connector assembly 6310 may be formed of a metallic material or magnetic material such that a separate carrier or magnet need not be necessary.
  • Shell magnet carrier 6214 includes an upper surface 6248 and an upper flange surface 6250. Upper surface 6248 and upper flange surface 6250 are spaced from each other by outer wall 6252. As seen in particular in Fig. 17, outer wall 6252 tapers inward toward the center of shell magnet carrier 6214 from upper surface 6248 to upper flange surface 6250. As described previously, this angled outer wall 6252 may cooperate with the front lip 6314 of connector 6316 to assist in retaining conduit connector assembly 6310 in place during use of patient interface 6000. Outer wall 6252 may be substantially linear along the height of shell magnet carrier 6214.
  • outer wall 6252 may have a substantially flat line orientation in a height direction.
  • Flange 6254 extends outwardly from outer wall 6252.
  • Flange 6254 may be situated within shell channel 6244 of shell 6220 By forming flange 6254 to fit within shell channel 6244 the likelihood of shell magnet carrier 6214 translating during use is minimized.
  • Flange 6254 may be pressed between raised platform 6240 and the outer wall of shell channel 6244. This may prevent or reduce the movement of shell magnet carrier 6214 with respect to shell 6220.
  • shell magnet carrier 6214 includes a central wall 6256.
  • Central wall 6256 defines shell magnet carrier opening 6258 which forms a portion of shell opening 6212.
  • central wall 6256 extends along the inner wall of raised platform 6240, and defines a portion of shell opening 6212. Further, central wall 6256 also defines a boundary of groove 6242 within shell magnet carrier 6214.
  • the length and shape of central wall 6256 may be modified depending on the shape of raised platform 6240 as well as the desired shape of shell opening 6212. Central wall 6256 may extend beyond the lower boundaries of shell magnet 6218 so as to limit air leakage through shell magnet carrier opening 6258 to shell magnet 6218.
  • shell magnet carrier 6214 is formed of a conformable material such as a rubber, liquid silicone, or elastomeric material. As depicted in Figs. 6-15 and 16-18, shell magnet carrier 6214 is formed of an elastomeric or rubber material. This material construction permits shell magnet carrier 6214 to reduce the quantity of air leakage through shell assembly 6200. In other forms, shell magnet carrier 6214 may be formed of other materials such as polycarbonate materials, metal, hard plastic, silicone or other materials. As depicted in Figs. 25 and 26, alternative forms of shell magnet carrier 6214 are utilized with seals or O-rings.
  • Conduit magnet carrier 6336 includes an upper surface 6344. This surface is configured to be oriented toward upper surface 6248 when patient interface 6000 is worn.
  • An outer wall 6346 tapers outward from upper surface 6248 such that the outer wall 6346 has a greater circumference farther away from upper surface 6248.
  • Outer wall 6346 may be arranged in such a manner so as to not interfere with the front lip 6314 as well as the upper and lower lips 6330, 6332 of connector 6316.
  • conduit magnet carrier 6336 includes a central wall 6348.
  • Central wall 6348 defines a portion of the flow path of air 6304 that flows through conduit connector assembly 6310 and to shell assembly 6200. Further, the outer wall 6346 and central wall 6348 may form the boundaries of groove 6342 in which conduit magnet 6318 is positioned. The shape, size, and orientation of conduit magnet carrier 6336 may be changed or altered depending on the particular design criteria of conduit connector assembly 6310.
  • conduit magnet carrier 6336 is formed of an elastomeric or rubber material. Such material may be utilized to form a seal between shell magnet carrier 6214 and conduit magnet carrier 6336 thereby limiting the quantity of air that may leak between conduit connector assembly 6310 and shell assembly 6200. Further, the material may also assist in limiting the quantity of air that is able to pass between connector 6316 and conduit magnet carrier 6336 or conduit magnet 6318. Other material configurations may be utilized.
  • conduit magnet carrier 6336 may be formed of polycarbonate, hard plastic, soft plastic, silicone, metal or other material.
  • connector 6316 includes a planar layer 6350.
  • Planar layer 6350 includes a curved edge 6352 that extends between and connects first and second edges 6354, 6356. Opposite of curved edge is third edge 6358 that extends between first and second edges 6354, 6356.
  • connector 6316 also includes a projecting wall 6360 that projects away from layer 6350. In some forms, projecting wall 6360 may angle inward, however in other forms projecting wall 6360 may be substantially orthogonal to layer 6350. Projecting wall 6360 is oriented along the edges of layer 6350.
  • projecting wall 6360 extends along curved edge 6352, first edge 6354 and second edge 6356. Additionally, projecting wall 6360 is not shown extending along third edge 6358. By not including a projecting wall along third edge 6358 conduit connector assembly 6310 may be permitted to be removed by pushing or pressing connector 6316 such that third edge 6358 moves toward shell magnet carrier 6214.
  • Projecting wall 6360 may have different widths or depths depending on the location along connector 6316. As described previously, connector 6316 may include front lip 6314, as well as upper and lower lips 6330, 6332. These lip portions have greater depths than adjacent portions of projecting wall 6360. This lip portions may be utilized to grab or engage with shell magnet carrier 6214 during use of patient interface 6000. Other portions of projecting wall 6360 may assist in providing a rigidity to connector 6316 so as to reduce the likelihood of occlusion of headgear conduit 6302 during use.
  • connector 6316 includes raised platform 6340.
  • Raised platform 6340 may be provided to allow for simple manufacturing such that the location of conduit magnet 6318 and conduit magnet carrier 6336 is readily obvious. Further, raised platform 6340 may also assist in restricting or restraining lateral movement of conduit magnet carrier 6336 with respect to connector 6316.
  • connector 6316 is formed of a plastic material such as polycarbonate.
  • the hard plastic material of connector 6316 may assist in providing a stable and sturdy structure to which to secure conduit magnet 6318 and conduit magnet carrier 6336.
  • connector 6316 may be formed of a different hard plastic, a soft plastic, silicone, rubber or an elastomeric material.
  • both shell magnet carrier 6214 and conduit magnet carrier 6336 are formed of plastic.
  • Add-on seals 6400 may be formed of a rubber, elastomeric, or other seal providing material.
  • Add-on seals 6400 may be secured to either or both of shell magnet carrier 6214 and conduit magnet carrier 6336 after each component has been formed. As shown add-on seals 6400 extend along the interior faces of conduit magnet carrier 6336 and shell magnet carrier 6214.
  • add-on seals 6400 may only extend partially along the carriers. As shown, the add-on seals 6400 abut one another at the junction between shell assembly 6200 and conduit connector assembly 6310. This may reduce the quantity of air leakage at the junction.
  • one or the other of conduit magnet carrier 6336 and shell magnet carrier 6214 may be formed of rubber or elastomeric material such as described with reference to Figs. 5-14. In such forms, if the carrier is formed of a seal-type material, it may not be necessary to include an add-on seal on the carrier.
  • conduit magnet carrier 6336 may be formed of a seal-type material.
  • Shell magnet carrier 6214 may be formed of a hard plastic material with poor sealing properties. Shell magnet carrier 6214 therefore may include an add-on seal 6400 while conduit magnet carrier 6336 may not include an add-on seal 6400.
  • shell magnet carrier 6214 and conduit magnet carrier 6336 include overmold seals 6410.
  • Overmold seals 6410 may be over molded onto one or both of shell magnet carrier 6214 and conduit magnet carrier 6336. As describe with reference to Fig. 25, however, the material of shell magnet carrier 6214 or conduit magnet carrier 6336 may be changed such that only one of the carrier includes overmold seals 6410. In some forms, additional seals such as O-ring seals may be utilized. In such forms the carriers may include a groove in the upper surfaces to accept the O-ring seals.
  • shell magnet carrier 6214 may utilize overmold seal 6410 and conduit magnet carrier 6336 may be formed of rubber and not utilize a separate seal.
  • shell magnet carrier 6214 may utilize an add on seal 6400 while conduit magnet carrier 6336 utilizes an overmold seal 6410. Any combination of seals and materials may be utilized to form an adequately sealed junction between shell assembly 6200 and conduit connector assembly 6310.
  • patient interface 7000 includes a mask assembly 7050 and an air delivery conduit connection assembly 7310.
  • Mask assembly 7050 may include a magnet that is configured to attract a magnet associated with air conduit connection assembly 7310.
  • mask assembly 7050 may include a magnet carrier similar to shell magnet carrier 6214.
  • air delivery conduit connection assembly 7310 may include a magnet carrier similar to conduit magnet carrier 6336.
  • an air delivery conduit may be connected to a full face mask that includes a magnetic connection.
  • headgear 6300 includes connection port 6600 and air circuit 4170.
  • Connection port 6600 may be equipped with an inset magnet to associate connection port 6600 with end 6602 of air circuit 4170.
  • End 6602 of air circuit 4170 may also include a magnet so that end 6602 may magnetically connect with connection port 6600.
  • air may be able to pass from air circuit 4170 and through connection port 6600.
  • the magnetic connections described in this specification may be utilized in other areas of a patient interface.
  • different configurations of patient interfaces may include similar features. For example patient interface 7000, although a full face mask with a different configuration than patient interface 6000 may still utilized a magnetic connection between various components.
  • the seal-forming structure includes a sealing flange utilizing a pressure assisted sealing mechanism.
  • the sealing flange can readily respond to a system positive pressure in the interior of the plenum chamber 3200 acting on its underside to urge it into tight sealing engagement with the face.
  • the pressure assisted mechanism may act in conjunction with elastic tension in the positioning and stabilising structure.
  • the seal-forming structure 3100 comprises a sealing flange and a support flange.
  • the sealing flange comprises a relatively thin member with a thickness of less than about lmm, for example about 0.25mm to about 0.45mm, which extends around the perimeter of the plenum chamber 3200.
  • Support flange may be relatively thicker than the sealing flange.
  • the support flange is disposed between the sealing flange and the marginal edge of the plenum chamber 3200, and extends at least part of the way around the perimeter.
  • the support flange is or includes a spring like element and functions to support the sealing flange from buckling in use.
  • the seal-forming structure may comprise a compression sealing portion or a gasket sealing portion.
  • the compression sealing portion, or the gasket sealing portion is constructed and arranged to be in compression, e.g. as a result of elastic tension in the positioning and stabilising structure.
  • the seal-forming structure comprises a tension portion.
  • the tension portion is held in tension, e.g. by adjacent regions of the sealing flange.
  • the seal-forming structure comprises a region having a tacky or adhesive surface.
  • a seal-forming structure may comprise one or more of a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tension portion, and a portion having a tacky or adhesive surface.
  • the non-invasive patient interface 3000 comprises a seal forming structure that forms a seal in use on a nose bridge region or on a nose-ridge region of the patient's face.
  • the seal-forming structure includes a saddle-shaped region constructed to form a seal in use on a nose bridge region or on a nose-ridge region of the patient's face.
  • the non-invasive patient interface 3000 comprises a seal forming structure that forms a seal in use on an upper lip region (that is, the lip superior) of the patient's face.
  • the seal-forming structure includes a saddle-shaped region constructed to form a seal in use on an upper lip region of the patient's face. 8.3.2.4 Chin-region
  • the non-invasive patient interface 3000 comprises a seal forming structure that forms a seal in use on a chin-region of the patient's face.
  • the seal-forming structure includes a saddle-shaped region constructed to form a seal in use on a chin-region of the patient's face.
  • the seal-forming structure that forms a seal in use on a forehead region of the patient's face may cover the eyes in use.
  • the seal-forming structure of the non-invasive patient interface 3000 comprises a pair of nasal puffs, or nasal pillows, each nasal puff or nasal pillow being constructed and arranged to form a seal with a respective naris of the nose of a patient.
  • Nasal pillows in accordance with an aspect of the present technology include: a frusto-cone, at least a portion of which forms a seal on an underside of the patient's nose, a stalk, a flexible region on the underside of the frusto-cone and connecting the frusto-cone to the stalk.
  • the structure to which the nasal pillow of the present technology is connected includes a flexible region adjacent the base of the stalk.
  • the flexible regions can act in concert to facilitate a universal joint structure that is accommodating of relative movement both displacement and angular of the frusto-cone and the structure to which the nasal pillow is connected.
  • the frusto-cone may be axially displaced towards the structure to which the stalk is connected.
  • the plenum chamber 3200 has a perimeter that is shaped to be complementary to the surface contour of the face of an average person in the region where a seal will form in use. In use, a marginal edge of the plenum chamber 3200 is positioned in close proximity to an adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100.
  • the seal-forming structure 3100 may extend in use about the entire perimeter of the plenum chamber 3200. In some forms, the plenum chamber 3200 and the seal- forming structure 3100 are formed from a single homogeneous piece of material.
  • the plenum chamber 3200 does not cover the eyes of the patient in use. In other words, the eyes are outside the pressurised volume defined by the plenum chamber. Such forms tend to be less obtrusive and / or more comfortable for the wearer, which can improve compliance with therapy.
  • the plenum chamber 3200 is constructed from a transparent material, e.g. a transparent polycarbonate.
  • a transparent material can reduce the obtrusiveness of the patient interface, and help improve compliance with therapy.
  • the use of a transparent material can aid a clinician to observe how the patient interface is located and functioning.
  • the plenum chamber 3200 is constructed from a translucent material.
  • a translucent material can reduce the obtrusiveness of the patient interface, and help improve compliance with therapy.
  • the seal-forming structure 3100 of the patient interface 3000 of the present technology may be held in sealing position in use by the positioning and stabilising structure 3300.
  • the positioning and stabilising structure 3300 provides a retention force at least sufficient to overcome the effect of the positive pressure in the plenum chamber 3200 to lift off the face.
  • the positioning and stabilising structure 3300 provides a retention force to overcome the effect of the gravitational force on the patient interface 3000.
  • the positioning and stabilising structure 3300 provides a retention force as a safety margin to overcome the potential effect of disrupting forces on the patient interface 3000, such as from tube drag, or accidental interference with the patient interface.
  • a positioning and stabilising structure 3300 is provided that is configured in a manner consistent with being worn by a patient while sleeping.
  • the positioning and stabilising structure 3300 has a low profile, or cross-sectional thickness, to reduce the perceived or actual bulk of the apparatus.
  • the positioning and stabilising structure 3300 comprises at least one strap having a rectangular cross-section.
  • the positioning and stabilising structure 3300 comprises at least one flat strap.
  • a positioning and stabilising structure 3300 is provided that is configured so as not to be too large and bulky to prevent the patient from lying in a supine sleeping position with a back region of the patient’s head on a pillow.
  • a positioning and stabilising structure 3300 is provided that is configured so as not to be too large and bulky to prevent the patient from lying in a side sleeping position with a side region of the patient’s head on a pillow.
  • a positioning and stabilising structure 3300 is provided with a decoupling portion located between an anterior portion of the positioning and stabilising structure 3300, and a posterior portion of the positioning and stabilising structure 3300.
  • the decoupling portion does not resist compression and may be, e.g. a flexible or floppy strap.
  • the decoupling portion is constructed and arranged so that when the patient lies with their head on a pillow, the presence of the decoupling portion prevents a force on the posterior portion from being transmitted along the positioning and stabilising structure 3300 and disrupting the seal.
  • a positioning and stabilising structure 3300 comprises a strap constructed from a laminate of a fabric patient contacting layer, a foam inner layer and a fabric outer layer.
  • the foam is porous to allow moisture, (e.g., sweat), to pass through the strap.
  • the fabric outer layer comprises loop material to engage with a hook material portion.
  • a positioning and stabilising structure 3300 comprises a strap that is extensible, e.g. resiliently extensible.
  • the strap may be configured in use to be in tension, and to direct a force to draw a seal-forming structure into sealing contact with a portion of a patient’s face.
  • the strap may be configured as a tie.
  • the positioning and stabilising structure comprises a first tie, the first tie being constructed and arranged so that in use at least a portion of an inferior edge thereof passes superior to an otobasion superior of the patient’s head and overlays a portion of the parietal bone without overlaying the occipital bone.
  • the positioning and stabilising structure includes a second tie, the second tie being constructed and arranged so that in use at least a portion of a superior edge thereof passes inferior to an otobasion inferior of the patient’ s head and overlays or lies inferior to the occipital bone of the patient’s head.
  • the positioning and stabilising structure includes a third tie that is constructed and arranged to interconnect the first tie and the second tie to reduce a tendency of the first tie and the second tie to move apart from one another.
  • a positioning and stabilising structure 3300 comprises a strap that is bendable and e.g. non-rigid.
  • An advantage of this aspect is that the strap is more comfortable for a patient to lie upon while the patient is sleeping.
  • a positioning and stabilising structure 3300 comprises a strap constructed to be breathable to allow moisture vapour to be transmitted through the strap.
  • a system comprising more than one positioning and stabilizing structure 3300, each being configured to provide a retaining force to correspond to a different size and/or shape range.
  • the system may comprise one form of positioning and stabilizing structure 3300 suitable for a large sized head, but not a small sized head, and another suitable for a small sized head, but not a large sized head.
  • the patient interface 3000 includes a vent 3400 constructed and arranged to allow for the washout of exhaled gases, e.g. carbon dioxide.
  • exhaled gases e.g. carbon dioxide.
  • the vent 3400 is configured to allow a continuous vent flow from an interior of the plenum chamber 3200 to ambient whilst the pressure within the plenum chamber is positive with respect to ambient.
  • the vent 3400 is configured such that the vent flow rate has a magnitude sufficient to reduce rebreathing of exhaled C02 by the patient while maintaining the therapeutic pressure in the plenum chamber in use.
  • vent 3400 in accordance with the present technology comprises a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.
  • the vent 3400 may be located in the plenum chamber 3200 or shell 6220. Alternatively, the vent 3400 is located in a decoupling structure, e.g., a swivel or within headgear conduit 6302 or adjacent conduit connector assembly 6310.
  • a decoupling structure e.g., a swivel or within headgear conduit 6302 or adjacent conduit connector assembly 6310.
  • the patient interface 3000 includes at least one decoupling structure, for example, a swivel or a ball and socket.
  • Connection port 3600 allows for connection to the air circuit 4170.
  • the patient interface 3000 includes a forehead support 3700.
  • the patient interface 3000 includes an anti-asphyxia valve. 8.3.10 Ports
  • a patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one form this allows a clinician to supply supplemental oxygen. In one form, this allows for the direct measurement of a property of gases within the plenum chamber 3200, such as the pressure.
  • An RPT device 4000 in accordance with one aspect of the present technology comprises mechanical, pneumatic, and/or electrical components and is configured to execute one or more algorithms 4300, such as any of the methods, in whole or in part, described herein.
  • the RPT device 4000 may be configured to generate a flow of air for delivery to a patient’s airways, such as to treat one or more of the respiratory conditions described elsewhere in the present document.
  • the RPT device 4000 is constructed and arranged to be capable of delivering a flow of air in a range of -20 L/min to +150 L/min while maintaining a positive pressure of at least 6 cmTbO, or at least lOcmtbO, or at least 20 cmtbO.
  • the RPT device may have an external housing 4010, formed in two parts, an upper portion 4012 and a lower portion 4014. Furthermore, the external housing 4010 may include one or more panel(s) 4015.
  • the RPT device 4000 comprises a chassis 4016 that supports one or more internal components of the RPT device 4000.
  • the RPT device 4000 may include a handle 4018.
  • the pneumatic path of the RPT device 4000 may comprise one or more air path items, e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 capable of supplying air at positive pressure (e.g., a blower 4142), an outlet muffler 4124 and one or more transducers 4270, such as pressure sensors 4272 and flow rate sensors 4274.
  • air path items e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 capable of supplying air at positive pressure (e.g., a blower 4142), an outlet muffler 4124 and one or more transducers 4270, such as pressure sensors 4272 and flow rate sensors 4274.
  • One or more of the air path items may be located within a removable unitary structure which will be referred to as a pneumatic block 4020.
  • the pneumatic block 4020 may be located within the external housing 4010. In one form a pneumatic block 4020 is supported by, or formed as part of the chassis 4016.
  • the RPT device 4000 may have an electrical power supply 4210, one or more input devices 4220, a central controller 4230, a therapy device controller 4240, a pressure generator 4140, one or more protection circuits 4250, memory 4260, transducers 4270, data communication interface 4280 and one or more output devices 4290. Electrical components 4200 may be mounted on a single Printed Circuit Board Assembly (PCBA) 4202. In an alternative form, the RPT device 4000 may include more than one PCBA 4202.
  • PCBA Printed Circuit Board Assembly
  • An RPT device may comprise one or more of the following components in an integral unit. In an alternative form, one or more of the following components may be located as respective separate units.
  • An RPT device in accordance with one form of the present technology may include an air filter 4110, or a plurality of air filters 4110.
  • an inlet air filter 4112 is located at the beginning of the pneumatic path upstream of a pressure generator 4140.
  • an outlet air filter 4114 for example an antibacterial filter, is located between an outlet of the pneumatic block 4020 and a patient interface 3000.
  • An RPT device in accordance with one form of the present technology may include a muffler 4120, or a plurality of mufflers 4120.
  • an inlet muffler 4122 is located in the pneumatic path upstream of a pressure generator 4140.
  • an outlet muffler 4124 is located in the pneumatic path between the pressure generator 4140 and a patient interface 3000. 8.4.1.3 Pressure generator
  • a pressure generator 4140 for producing a flow, or a supply, of air at positive pressure is a controllable blower 4142.
  • the blower 4142 may include a brushless DC motor 4144 with one or more impellers housed in a blower housing, such as in a volute.
  • the blower may be capable of delivering a supply of air, for example at a rate of up to about 120 litres/minute, at a positive pressure in a range from about 4 cmFbO to about 20 cmFbO, or in other forms up to about 30 cmFbO.
  • the blower may be as described in any one of the following patents or patent applications the contents of which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application Publication No. WO 2013/020167.
  • the pressure generator 4140 is under the control of the therapy device controller 4240.
  • a pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high pressure source (e.g. compressed air reservoir), or a bellows.
  • a motor speed transducer 4276 is used to determine a rotational velocity of the motor 4144 and/or the blower 4142.
  • a motor speed signal from the motor speed transducer 4276 may be provided to the therapy device controller 4240.
  • the motor speed transducer 4276 may, for example, be a speed sensor, such as a Hall effect sensor.
  • an anti-spill back valve 4160 is located between the humidifier 5000 and the pneumatic block 4020.
  • the anti-spill back valve is constructed and arranged to reduce the risk that water will flow upstream from the humidifier 5000, for example to the motor 4144. 8.4.1.5 Clock
  • the RPT device 4000 may include a clock 4232 that is connected to the central controller 4230.
  • a data communication interface 4280 is provided, and is connected to the central controller 4230.
  • Data communication interface 4280 may be connectable to a remote external communication network 4282 and/or a local external communication network 4284.
  • the remote external communication network 4282 may be connectable to a remote external device 4286.
  • the local external communication network 4284 may be connectable to a local external device 4288.
  • An output device 4290 in accordance with the present technology may take the form of one or more of a visual, audio and haptic unit.
  • a visual display may be a Liquid Crystal Display (LCD) or Light Emitting Diode (LED) display.
  • a display driver 4292 receives as an input the characters, symbols, or images intended for display on the display 4294, and converts them to commands that cause the display 4294 to display those characters, symbols, or images.
  • An air circuit 4170 in accordance with an aspect of the present technology is a conduit or a tube constructed and arranged to allow, in use, a flow of air to travel between two components such as RPT device 4000 and the patient interface 3000.
  • the air circuit 4170 may be in fluid connection with the outlet of the pneumatic block 4020 and the patient interface.
  • the air circuit may be referred to as an air delivery tube.
  • the air circuit 4170 may comprise one or more heating elements configured to heat air in the air circuit, for example to maintain or raise the temperature of the air.
  • the heating element may be in a form of a heated wire circuit, and may comprise one or more transducers, such as temperature sensors.
  • the heated wire circuit may be helically wound around the axis of the air circuit 4170.
  • the heating element may be in communication with a controller such as a central controller 4230.
  • a controller such as a central controller 4230.
  • supplemental oxygen 4180 is delivered to one or more points in the pneumatic path, such as upstream of the pneumatic block 4020, to the air circuit 4170 and/or to the patient interface 3000.
  • a humidifier 5000 (e.g. as shown in Fig. 5A) to change the absolute humidity of air or gas for delivery to a patient relative to ambient air.
  • the humidifier 5000 is used to increase the absolute humidity and increase the temperature of the flow of air (relative to ambient air) before delivery to the patient’s airways.
  • the humidifier 5000 may comprise a humidifier reservoir 5110, a humidifier inlet 5002 to receive a flow of air, and a humidifier outlet 5004 to deliver a humidified flow of air.
  • a humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004 respectively.
  • the humidifier 5000 may further comprise a humidifier base 5006, which may be adapted to receive the humidifier reservoir 5110 and comprise a heating element 5240.
  • the reservoir 5110 comprises a conductive portion 5120 configured to allow efficient transfer of heat from the heating element 5240 to the volume of liquid in the reservoir 5110.
  • the conductive portion 5120 may be arranged as a plate, although other shapes may also be suitable. All or a part of the conductive portion 5120 may be made of a thermally conductive material such as aluminium (e.g. approximately 2 mm thick, such as 1 mm, 1.5 mm, 2.5 mm or 3 mm), another heat conducting metal or some plastics. In some cases, suitable heat conductivity may be achieved with less conductive materials of suitable geometry.
  • the humidifier 5000 may comprise a humidifier reservoir dock 5130 (as shown in Fig. 5B) configured to receive the humidifier reservoir 5110.
  • the humidifier reservoir dock 5130 may comprise a locking feature such as a locking lever 5135 configured to retain the reservoir 5110 in the humidifier reservoir dock 5130.
  • the humidifier reservoir 5110 may comprise a water level indicator 5150 as shown in Fig. 5A-5B.
  • the water level indicator 5150 may provide one or more indications to a user such as the patient 1000 or a care giver regarding a quantity of the volume of water in the humidifier reservoir 5110.
  • the one or more indications provided by the water level indicator 5150 may include an indication of a maximum, predetermined volume of water, any portions thereof, such as 25%, 50% or 75% or volumes such as 200 ml, 300 ml or 400ml.
  • Air In certain forms of the present technology, air may be taken to mean atmospheric air, and in other forms of the present technology air may be taken to mean some other combination of breathable gases, e.g. atmospheric air enriched with oxygen.
  • Ambienf In certain forms of the present technology, the term ambient will be taken to mean (i) external of the treatment system or patient, and (ii) immediately surrounding the treatment system or patient.
  • ambient humidity with respect to a humidifier may be the humidity of air immediately surrounding the humidifier, e.g. the humidity in the room where a patient is sleeping. Such ambient humidity may be different to the humidity outside the room where a patient is sleeping.
  • ambient pressure may be the pressure immediately surrounding or external to the body.
  • ambient noise may be considered to be the background noise level in the room where a patient is located, other than for example, noise generated by an RPT device or emanating from a mask or patient interface.
  • Ambient noise may be generated by sources outside the room.
  • APAP therapy in which the treatment pressure is automatically adjustable, e.g. from breath to breath, between minimum and maximum limits, depending on the presence or absence of indications of SDB events.
  • Continuous Positive Airway Pressure (CPAP ) therapy Respiratory pressure therapy in which the treatment pressure is approximately constant through a respiratory cycle of a patient.
  • the pressure at the entrance to the airways will be slightly higher during exhalation, and slightly lower during inhalation.
  • the pressure will vary between different respiratory cycles of the patient, for example, being increased in response to detection of indications of partial upper airway obstruction, and decreased in the absence of indications of partial upper airway obstruction.
  • Flow rate The volume (or mass) of air delivered per unit time. Flow rate may refer to an instantaneous quantity. In some cases, a reference to flow rate will be a reference to a scalar quantity, namely a quantity having magnitude only. In other cases, a reference to flow rate will be a reference to a vector quantity, namely a quantity having both magnitude and direction. Flow rate may be given the symbol Q. ‘Flow rate’ is sometimes shortened to simply‘flow’ or‘airflow’.
  • a flow rate may be nominally positive for the inspiratory portion of a breathing cycle of a patient, and hence negative for the expiratory portion of the breathing cycle of a patient.
  • Total flow rate, Qt is the flow rate of air leaving the RPT device.
  • Vent flow rate, Qv is the flow rate of air leaving a vent to allow washout of exhaled gases.
  • Leak flow rate, Ql is the flow rate of leak from a patient interface system or elsewhere.
  • Respiratory flow rate, Qr is the flow rate of air that is received into the patient's respiratory system.
  • Humidifier will be taken to mean a humidifying apparatus constructed and arranged, or configured with a physical structure to be capable of providing a therapeutically beneficial amount of water (FLO) vapour to a flow of air to ameliorate a medical respiratory condition of a patient.
  • FLO water
  • Leak The word leak will be taken to be an unintended flow of air. In one example, leak may occur as the result of an incomplete seal between a mask and a patient's face. In another example leak may occur in a swivel elbow to the ambient.
  • Noise, conducted (acoustic) Conducted noise in the present document refers to noise which is carried to the patient by the pneumatic path, such as the air circuit and the patient interface as well as the air therein.
  • conducted noise may be quantified by measuring sound pressure levels at the end of an air circuit.
  • Radiated noise in the present document refers to noise which is carried to the patient by the ambient air.
  • radiated noise may be quantified by measuring sound power/pressure levels of the object in question according to ISO 3744.
  • Vent noise in the present document refers to noise which is generated by the flow of air through any vents such as vent holes of the patient interface.
  • Pressure Force per unit area. Pressure may be expressed in a range of units, including crnFLO, g-f/cm 2 and hectopascal. 1 cmFbO is equal to 1 g-f/cm 2 and is approximately 0.98 hectopascal. In this specification, unless otherwise stated, pressure is given in units of cmFbO.
  • the pressure in the patient interface is given the symbol Pm, while the treatment pressure, which represents a target value to be achieved by the mask pressure Pm at the current instant of time, is given the symbol Pt.
  • Respiratory Pressure Therapy The application of a supply of air to an entrance to the airways at a treatment pressure that is typically positive with respect to atmosphere.
  • Ventilator A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.
  • Silicone or Silicone Elastomer A synthetic rubber.
  • a reference to silicone is a reference to liquid silicone rubber (LSR) or a compression moulded silicone rubber (CMSR).
  • LSR liquid silicone rubber
  • CMSR compression moulded silicone rubber
  • SILASTIC included in the range of products sold under this trademark
  • Another manufacturer of LSR is Wacker.
  • an exemplary form of LSR has a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.
  • Polycarbonate a thermoplastic polymer of Bisphenol-A Carbonate.
  • Resilience Ability of a material to absorb energy when deformed elastically and to release the energy upon unloading.
  • Resilient Will release substantially all of the energy when unloaded. Includes e.g. certain silicones, and thermoplastic elastomers.
  • Hardness The ability of a material per se to resist deformation (e.g. described by a Young’s Modulus, or an indentation hardness scale measured on a standardised sample size).
  • Soft materials may include silicone or thermo-plastic elastomer (TPE), and may, e.g. readily deform under finger pressure.
  • TPE thermo-plastic elastomer
  • Hard materials may include polycarbonate, polypropylene, steel or
  • aluminium may not e.g. readily deform under finger pressure.
  • Stiffness (or rigidity) of a structure or component The ability of the structure or component to resist deformation in response to an applied load.
  • the load may be a force or a moment, e.g. compression, tension, bending or torsion.
  • the structure or component may offer different resistances in different directions.
  • Floppy structure or component A structure or component that will change shape, e.g. bend, when caused to support its own weight, within a relatively short period of time such as 1 second.
  • Rigid structure or component A structure or component that will not substantially change shape when subject to the loads typically encountered in use.
  • An example of such a use may be setting up and maintaining a patient interface in sealing relationship with an entrance to a patient's airways, e.g. at a load of approximately 20 to 30 crrd bO pressure.
  • an I-beam may comprise a different bending stiffness (resistance to a bending load) in a first direction in comparison to a second, orthogonal direction.
  • a structure or component may be floppy in a first direction and rigid in a second direction.
  • an apnea is said to have occurred when flow falls below a predetermined threshold for a duration, e.g. 10 seconds.
  • An obstructive apnea will be said to have occurred when, despite patient effort, some obstruction of the airway does not allow air to flow.
  • a central apnea will be said to have occurred when an apnea is detected that is due to a reduction in breathing effort, or the absence of breathing effort, despite the airway being patent.
  • a mixed apnea occurs when a reduction or absence of breathing effort coincides with an obstructed airway.
  • Breathing rate The rate of spontaneous respiration of a patient, usually measured in breaths per minute.
  • Duty cycle The ratio of inhalation time, Ti to total breath time, Ttot.
  • Effort ( breathing ) The work done by a spontaneously breathing person attempting to breathe.
  • Expiratory portion of a breathing cycle The period from the start of expiratory flow to the start of inspiratory flow.
  • Flow limitation will be taken to be the state of affairs in a patient's respiration where an increase in effort by the patient does not give rise to a corresponding increase in flow. Where flow limitation occurs during an inspiratory portion of the breathing cycle it may be described as inspiratory flow limitation. Where flow limitation occurs during an expiratory portion of the breathing cycle it may be described as expiratory flow limitation.
  • hypopnea is taken to be a reduction in flow, but not a cessation of flow.
  • a hypopnea may be said to have occurred when there is a reduction in flow below a threshold rate for a duration.
  • a central hypopnea will be said to have occurred when a hypopnea is detected that is due to a reduction in breathing effort.
  • either of the following may be regarded as being hypopneas:
  • Hyperpnea An increase in flow to a level higher than normal.
  • Inspiratory portion of a breathing cycle The period from the start of inspiratory flow to the start of expiratory flow will be taken to be the inspiratory portion of a breathing cycle.
  • Patency airway: The degree of the airway being open, or the extent to which the airway is open. A patent airway is open. Airway patency may be quantified, for example with a value of one (1) being patent, and a value of zero (0), being closed (obstructed).
  • PEEP Positive End-Expiratory Pressure
  • Peak flow rate The maximum value of flow rate during the inspiratory portion of the respiratory flow waveform.
  • Tidal volume (Vt) The volume of air inhaled or exhaled during normal breathing, when extra effort is not applied.
  • the inspiratory volume Vi (the volume of air inhaled) is equal to the expiratory volume Ve (the volume of air exhaled), and therefore a single tidal volume Vt may be defined as equal to either quantity.
  • the tidal volume Vt is estiated as some combination, e.g. the mean, of the inspiratory volume Vi and the expiratory volume Ve.
  • Typical recent ventilation The value of ventilation around which recent values of ventilation Vent over some predetermined timescale tend to cluster, that is, a measure of the central tendency of the recent values of ventilation.
  • Upper airway obstruction includes both partial and total upper airway obstruction. This may be associated with a state of flow limitation, in which the flow rate increases only slightly or may even decrease as the pressure difference across the upper airway increases (Starling resistor behaviour).
  • Ventilation A measure of a rate of gas being exchanged by the patient’s respiratory system. Measures of ventilation may include one or both of inspiratory and expiratory flow, per unit time. When expressed as a volume per minute, this quantity is often referred to as“minute ventilation”. Minute ventilation is sometimes given simply as a volume, understood to be the volume per minute.
  • Ala the external outer wall or "wing" of each nostril (plural: alar)
  • Alare The most lateral point on the nasal ala.
  • Alar curvature (or alar crest) point The most posterior point in the curved base line of each ala, found in the crease formed by the union of the ala with the cheek.
  • Auricle The whole external visible part of the ear.
  • (nose) Bony framework The bony framework of the nose comprises the nasal bones, the frontal process of the maxillae and the nasal part of the frontal bone.
  • (nose) Cartilaginous framework The cartilaginous framework of the nose comprises the septal, lateral, major and minor cartilages.
  • Columella the strip of skin that separates the nares and which runs from the pronasale to the upper lip.
  • Columella angle The angle between the line drawn through the midpoint of the nostril aperture and a line drawn perpendicular to the Frankfort horizontal while intersecting subnasale.
  • Glabella Located on the soft tissue, the most prominent point in the midsagittal plane of the forehead.
  • Lateral nasal cartilage A generally triangular plate of cartilage. Its superior margin is attached to the nasal bone and frontal process of the maxilla, and its inferior margin is connected to the greater alar cartilage.
  • Greater alar cartilage A plate of cartilage lying below the lateral nasal cartilage. It is curved around the anterior part of the naris. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane containing three or four minor cartilages of the ala.
  • Naso-labial sulcus or Naso-labial fold The skin fold or groove that runs from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.
  • Naso-labial angle The angle between the columella and the upper lip, while intersecting subnasale.
  • Otobasion inferior The lowest point of attachment of the auricle to the skin of the face.
  • Otobasion superior The highest point of attachment of the auricle to the skin of the face.
  • Pronasale the most protruded point or tip of the nose, which can be identified in lateral view of the rest of the portion of the head.
  • Philtrum the midline groove that runs from lower border of the nasal septum to the top of the lip in the upper lip region.
  • Pogonion Located on the soft tissue, the most anterior midpoint of the chin.
  • Ridge (nasal): The nasal ridge is the midline prominence of the nose, extending from the Sellion to the Pronasale.
  • Sagittal plane A vertical plane that passes from anterior (front) to posterior (rear).
  • the midsagittal plane is a sagittal plane that divides the body into right and left halves.
  • Septal cartilage (nasal): The nasal septal cartilage forms part of the septum and divides the front part of the nasal cavity.
  • Subalare The point at the lower margin of the alar base, where the alar base joins with the skin of the superior (upper) lip.
  • Subnasal point Located on the soft tissue, the point at which the columella merges with the upper lip in the midsagittal plane.
  • Supramenton The point of greatest concavity in the midline of the lower lip between labrale inferius and soft tissue pogonion
  • Frontal bone includes a large vertical portion, the squama frontalis, corresponding to the region known as the forehead.
  • Mandible forms the lower jaw.
  • the mental protuberance is the bony protuberance of the jaw that forms the chin.
  • Maxilla ⁇ The maxilla forms the upper jaw and is located above the mandible and below the orbits. The frontal process of the maxilla projects upwards by the side of the nose, and forms part of its lateral boundary.
  • Nasal bones are two small oblong bones, varying in size and form in different individuals; they are placed side by side at the middle and upper part of the face, and form, by their junction, the "bridge" of the nose.
  • Nasion The intersection of the frontal bone and the two nasal bones, a depressed area directly between the eyes and superior to the bridge of the nose.
  • Occipital bone The occipital bone is situated at the back and lower part of the cranium. It includes an oval aperture, the foramen magnum, through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the squama occipitalis.
  • Orbit The bony cavity in the skull to contain the eyeball.
  • Parietal bones The parietal bones are the bones that, when joined together, form the roof and sides of the cranium.
  • Temporal bones The temporal bones are situated on the bases and sides of the skull, and support that part of the face known as the temple.
  • Zygomatic bones The face includes two zygomatic bones, located in the upper and lateral parts of the face and forming the prominence of the cheek.
  • Diaphragm A sheet of muscle that extends across the bottom of the rib cage. The diaphragm separates the thoracic cavity, containing the heart, lungs and ribs, from the abdominal cavity. As the diaphragm contracts the volume of the thoracic cavity increases and air is drawn into the lungs.
  • Larynx The larynx, or voice box houses the vocal folds and connects the inferior part of the pharynx (hypopharynx) with the trachea.
  • Lungs The organs of respiration in humans.
  • the conducting zone of the lungs contains the trachea, the bronchi, the bronchioles, and the terminal bronchioles.
  • the respiratory zone contains the respiratory bronchioles, the alveolar ducts, and the alveoli.
  • Nasal cavity The nasal cavity (or nasal fossa) is a large air filled space above and behind the nose in the middle of the face.
  • the nasal cavity is divided in two by a vertical fin called the nasal septum.
  • On the sides of the nasal cavity are three horizontal outgrowths called nasal conchae (singular "concha") or turbinates.
  • nasal conchae singular "concha”
  • turbinates To the front of the nasal cavity is the nose, while the back blends, via the choanae, into the nasopharynx.
  • Pharynx The part of the throat situated immediately inferior to (below) the nasal cavity, and superior to the oesophagus and larynx.
  • the pharynx is conventionally divided into three sections: the nasopharynx (epipharynx) (the nasal part of the pharynx), the oropharynx (mesopharynx) (the oral part of the pharynx), and the laryngopharynx (hypopharynx).
  • Anti-asphyxia valve The component or sub-assembly of a mask system that, by opening to atmosphere in a failsafe manner, reduces the risk of excessive CO2 rebreathing by a patient.
  • Elbow An elbow is an example of a structure that directs an axis of flow of air travelling therethrough to change direction through an angle.
  • the angle may be approximately 90 degrees.
  • the angle may be more, or less than 90 degrees.
  • the elbow may have an approximately circular cross-section.
  • the elbow may have an oval or a rectangular cross-section.
  • an elbow may be rotatable with respect to a mating component, e.g. about 360 degrees.
  • an elbow may be removable from a mating component, e.g. via a snap connection.
  • an elbow may be assembled to a mating component via a one-time snap during manufacture, but not removable by a patient.
  • Frame will be taken to mean a mask structure that bears the load of tension between two or more points of connection with a headgear.
  • a mask frame may be a non-airtight load bearing structure in the mask. However, some forms of mask frame may also be air-tight.
  • Headgear will be taken to mean a form of positioning and stabilizing structure designed for use on a head.
  • the headgear may comprise a collection of one or more struts, ties and stiffeners configured to locate and retain a patient interface in position on a patient’s face for delivery of respiratory therapy.
  • Some ties are formed of a soft, flexible, elastic material such as a laminated composite of foam and fabric.
  • Membrane will be taken to mean a typically thin element that has, preferably, substantially no resistance to bending, but has resistance to being stretched.
  • Plenum chamber a mask plenum chamber will be taken to mean a portion of a patient interface having walls at least partially enclosing a volume of space, the volume having air therein pressurised above atmospheric pressure in use. A shell may form part of the walls of a mask plenum chamber.
  • Seal May be a noun form ("a seal") which refers to a structure, or a verb form (“to seal”) which refers to the effect. Two elements may be constructed and/or arranged to‘seal’ or to effect‘sealing’ therebetween without requiring a separate ‘seal’ element per se.
  • a shell will be taken to mean a curved, relatively thin structure having bending, tensile and compressive stiffness.
  • a curved structural wall of a mask may be a shell.
  • a shell may be faceted.
  • a shell may be airtight.
  • a shell may not be airtight.
  • Stiffener A stiffener will be taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.
  • Strut A strut will be taken to be a structural component designed to increase the compression resistance of another component in at least one direction.
  • Swivel A subassembly of components configured to rotate about a common axis, preferably independently, preferably under low torque.
  • the swivel may be constructed to rotate through an angle of at least 360 degrees.
  • the swivel may be constructed to rotate through an angle less than 360 degrees.
  • the sub-assembly of components preferably comprises a matched pair of cylindrical conduits. There may be little or no leak flow of air from the swivel in use.
  • Tie (noun): A structure designed to resist tension.
  • Vent (noun): A structure that allows a flow of air from an interior of the mask, or conduit, to ambient air for clinically effective washout of exhaled gases.
  • a clinically effective washout may involve a flow rate of about 10 litres per minute to about 100 litres per minute, depending on the mask design and treatment pressure.
  • Products in accordance with the present technology may comprise one or more three-dimensional mechanical structures, for example a mask cushion or an impeller.
  • the three-dimensional structures may be bounded by two-dimensional surfaces. These surfaces may be distinguished using a label to describe an associated surface orientation, location, function, or some other characteristic.
  • a structure may comprise one or more of an anterior surface, a posterior surface, an interior surface and an exterior surface.
  • a seal-forming structure may comprise a face-contacting (e.g. outer) surface, and a separate non-face- contacting (e.g. underside or inner) surface.
  • a structure may comprise a first surface and a second surface.
  • Fig. 3B to Fig. 3F illustrate examples of cross-sections at point p on a surface, and the resulting plane curves.
  • Figs. 3B to 3F also illustrate an outward normal vector at p.
  • the outward normal vector at p points away from the surface.
  • the curvature of a plane curve at p may be described as having a sign (e.g. positive, negative) and a magnitude (e.g. l/radius of a circle that just touches the curve at p).
  • a description of the shape at a given point on a two-dimensional surface in accordance with the present technology may include multiple normal cross- sections.
  • the multiple cross-sections may cut the surface in a plane that includes the outward normal (a“normal plane”), and each cross-section may be taken in a different direction.
  • Each cross-section results in a plane curve with a corresponding curvature.
  • the different curvatures at that point may have the same sign, or a different sign.
  • Each of the curvatures at that point has a magnitude, e.g. relatively small.
  • the plane curves in Figs. 3B to 3F could be examples of such multiple cross-sections at a particular point.
  • Region of a surface A connected set of points on a surface.
  • the set of points in a region may have similar characteristics, e.g. curvatures or signs.
  • Saddle region A region where at each point, the principal curvatures have opposite signs, that is, one is positive, and the other is negative (depending on the direction to which the imaginary person turns, they may walk uphill or downhill).
  • Dome region A region where at each point the principal curvatures have the same sign, e.g. both positive (a“concave dome”) or both negative (a“convex dome”).
  • Cylindrical region A region where one principal curvature is zero (or, for example, zero within manufacturing tolerances) and the other principal curvature is non-zero.
  • Planar region A region of a surface where both of the principal curvatures are zero (or, for example, zero within manufacturing tolerances).
  • Edge of a surface A boundary or limit of a surface or region.
  • Path In certain forms of the present technology,‘path’ will be taken to mean a path in the mathematical - topological sense, e.g. a continuous space curve from/(0) to /( 1 ) on a surface. In certain forms of the present technology, a‘path’ may be described as a route or course, including e.g. a set of points on a surface. (The path for the imaginary person is where they walk on the surface, and is analogous to a garden path).
  • Path length In certain forms of the present technology,‘path length’ will be taken to mean the distance along the surface from /(0) to/(l), that is, the distance along the path on the surface. There may be more than one path between two points on a surface and such paths may have different path lengths. (The path length for the imaginary person would be the distance they have to walk on the surface along the path).
  • Straight-line distance is the distance between two points on a surface, but without regard to the surface. On planar regions, there would be a path on the surface having the same path length as the straight-line distance between two points on the surface. On non-planar surfaces, there may be no paths having the same path length as the straight-line distance between two points. (For the imaginary person, the straight-line distance would correspond to the distance ‘as the crow flies’.)
  • Space curves Unlike a plane curve, a space curve does not necessarily lie in any particular plane.
  • a space curve may be closed, that is, having no endpoints.
  • a space curve may be considered to be a one-dimensional piece of three-dimensional space.
  • An imaginary person walking on a strand of the DNA helix walks along a space curve.
  • a typical human left ear comprises a helix, which is a left-hand helix, see Fig. 3Q.
  • a typical human right ear comprises a helix, which is a right-hand helix, see Fig. 3R.
  • Fig. 3S shows a right-hand helix.
  • the edge of a structure e.g.
  • a space curve may be described by a curvature and a torsion at each point on the space curve.
  • Torsion is a measure of how the curve turns out of a plane. Torsion has a sign and a magnitude.
  • the torsion at a point on a space curve may be characterised with reference to the tangent, normal and binormal vectors at that point.
  • Tangent unit vector (or unit tangent vector): For each point on a curve, a vector at the point specifies a direction from that point, as well as a magnitude. A tangent unit vector is a unit vector pointing in the same direction as the curve at that point. If an imaginary person were flying along the curve and fell off her vehicle at a particular point, the direction of the tangent vector is the direction she would be travelling.
  • Unit normal vector As the imaginary person moves along the curve, this tangent vector itself changes.
  • the unit vector pointing in the same direction that the tangent vector is changing is called the unit principal normal vector. It is
  • Binormal unit vector The binormal unit vector is perpendicular to both the tangent vector and the principal normal vector. Its direction may be determined by a right-hand rule (see e.g. Fig. 3P), or alternatively by a left-hand rule (Fig. 30).
  • Osculating plane The plane containing the unit tangent vector and the unit principal normal vector. See Figures 30 and 3P.
  • Torsion of a space curve The torsion at a point of a space curve is the magnitude of the rate of change of the binormal unit vector at that point. It measures how much the curve deviates from the osculating plane.
  • a space curve which lies in a plane has zero torsion.
  • a space curve which deviates a relatively small amount from the osculating plane will have a relatively small magnitude of torsion (e.g. a gently sloping helical path).
  • a space curve which deviates a relatively large amount from the osculating plane will have a relatively large magnitude of torsion (e.g. a steeply sloping helical path).
  • a space curve turning towards the direction of the right-hand binormal may be considered as having a right- hand positive torsion (e.g. a right-hand helix as shown in Fig. 3S).
  • a space curve turning away from the direction of the right-hand binormal may be considered as having a right-hand negative torsion (e.g. a left-hand helix).
  • a space curve turning towards the direction of the left-hand binormal may be considered as having a left-hand positive torsion (e.g. a left-hand helix).
  • Flence left-hand positive is equivalent to right-hand negative. See Fig. 3T.
  • a surface may have a one-dimensional hole, e.g. a hole bounded by a plane curve or by a space curve.
  • Thin structures e.g. a membrane
  • Thin structures with a hole, may be described as having a one-dimensional hole. See for example the one dimensional hole in the surface of structure shown in Fig. 31, bounded by a plane curve.
  • a structure may have a two-dimensional hole, e.g. a hole bounded by a surface.
  • a hole bounded by a surface For example, an inflatable tyre has a two dimensional hole bounded by the interior surface of the tyre.
  • a bladder with a cavity for air or gel could have a two-dimensional hole. See for example the cushion of Fig. 3L and the example cross-sections therethrough in Fig. 3M and Fig. 3N, with the interior surface bounding a two dimensional hole indicated.
  • a conduit may comprise a one-dimension hole (e.g. at its entrance or at its exit), and a two-dimension hole bounded by the inside surface of the conduit. See also the two dimensional hole through the structure shown in Fig. 3K, bounded by a surface as shown.
  • PCBA printed circuit board assembly

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  • Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Emergency Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Otolaryngology (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)
  • Accommodation For Nursing Or Treatment Tables (AREA)
  • Magnetic Treatment Devices (AREA)

Abstract

Dispositif de traitement qui comprend un conduit d'air qui est conçu à la fois pour assurer la fixation de l'interface patient au patient et pour fournir de l'air sous pression au patient. La structure de positionnement et de stabilisation de l'interface patient peut comprendre des aimants qui aident à positionner la structure de positionnement et de stabilisation et qui aident également à positionner le conduit d'air de la structure de positionnement et de stabilisation en vue de son interaction avec l'ensemble masque.
PCT/IB2019/052395 2018-03-29 2019-03-25 Conduit avec connecteur magnétique WO2019186361A1 (fr)

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EP19777027.4A EP3773846B1 (fr) 2018-03-29 2019-03-25 Conduit avec connecteur magnétique
US16/635,267 US10953180B2 (en) 2018-03-29 2019-03-25 Conduit with magnetic connector
EP23210412.5A EP4364772A3 (fr) 2018-03-29 2019-03-25 Conduit avec connecteur magnétique
US17/177,611 US20210170129A1 (en) 2018-03-29 2021-02-17 Conduit with magnetic connector

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US201862649941P 2018-03-29 2018-03-29
US62/649,941 2018-03-29

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US10953180B2 (en) 2021-03-23
EP3773846A4 (fr) 2021-12-22
US20200368477A1 (en) 2020-11-26
EP4364772A2 (fr) 2024-05-08
US20210170129A1 (en) 2021-06-10
EP3773846A1 (fr) 2021-02-17
EP3773846B1 (fr) 2023-11-29

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